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Medical Device Industry

NuGeneration Technologies, LLC has become one of the leading suppliers to the Medical Device Industry.  Our high quality custom formulated products have helped many of our customers improve their processes and yields.  We have a wide array of products for medical Device manufacturers.  The products in our Medical Device line all meet FDA requirements and are certified ACS grade or better.

PRODUCTS OFFERED:

PRODUCTS OFFERED (click on name for tech data sheets)

MSDS

NuGenTec EP 316 Medical Device Electro Polishing Process Chemical.  Great for Stainless steels, nickel alloys, titanium, nitinol, inconel, monel, hastelloy, waspalloy, ferrous and non ferrous metals.    EP 316 is formulated for the Medical Device Industry. 

bullet Meets FDA requirements
bullet Certified ACS Grade + (Ultra high purity)
bullet Improves surface finishes
bullet Aides in even and consistent EP from batch to batch

MSDS

NuWet DM 41:  Highly alkaline cleaner.  Soak, spray, sonicate (ultrasonic).  Rinses freely with DI water.  Formulated with the needs of the electronics and medical device industries in mind.  No Solvent will remove particles more effectively than DM 41.  DM 41 is an excellent cleaner and degreaser as well.

NuWet DM33: Highly alkaline cleaner for particle. Contains <10% solvent, ultrasonic cleaner, excels at particle removal after polishing and abrasive blasting of glass, aluminum oxide (Al2O3).

NuKlean DS 105:  NuKlean DS 105 a heavy duty acidic immersion/ ultrasonic cleaner for removing oxides, smut, oils, grease, fingerprints and ship dirt from stainless steel, aluminum, brass, copper, zinc, magnesium, titanium, zirconium and inconel. Also for Plastics, ceramics, glass, Silicon Carbide. The unique surfactant blend is especially good for wetting recessed surfaces such as tapped holes and tubes. Prevents oily materials from re-contaminating parts by emulsifying oils. At higher concentrations NuKlean DS 105 may be used for passivating Stainless steel. For best results passivating SS NuBrite C 50 is recommended. Contains only phosphoric acid so NuKlean DS 105 is a safer alternative to Sulfuric, Hydrofluoric and Nitric acid based products. NuKlean DS 105’s surfactant blend not only aids in cleaning but helps provide a more uniform passivation. Acid Cleaning compound, Phosphoric acid based.

MSDS

Formulated Sulfamic Acid Cleaners:  Acid Cleaning compound.  Sulfamic acid based.

MSDS

Nitric Acid:  Concentrations of Nitric acid from 1% to 70%.  Available in 500ml bottles to drum quantities.  Coronary nitric acid.

MSDS

Nitric Acid & HF Blends Nitric and Hydrofluoric Acid.  Many ratios available.  Please call or email for more information.

MSDS

 

 

i. NuGenTec EP 316 - Electro Polishing
ii. NuWet DM 41 Alkaline Medical Device & Electronics grade Cleaning Compound


FDAnews Device Daily Bulletin
FDA Asking Devicemakers to Help With Overseas Supply Oversight
The FDA is trying to stretch its enforcement reach over foreign device suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the supply chain.
Devicemakers Want More Clarity on Third-Party Audit Program
Devicemakers want more clarity on third-party audits by regulatory agencies in other countries, especially when it comes to possible enforcement actions.
FDA to Hold Device Nanotechnology Workshop
The FDA will hold a public workshop to get information on the manufacture, characterization and biocompatibility evaluation of devices and diagnostics using nanomaterials.
LEDs Illuminate Eye for Ocular Disease Screening
A new imaging system using six different wavelengths to illuminate the interior of the eyeball (ocular fundus) may pave the way for doctors to easily screen patients for common diseases of the eye, such as age-related macular degeneration and diabetic retinopathy.
Proposed Diabetes Test Misses Most Cases: Study
A new proposed diabetes test could miss millions of cases of diabetes and pre-diabetes and also over-diagnose black Americans if it was used as a screening tool, suggests a new study.
BSD Medical Tissue Device Is Safety Compliant
BSD Medical Corp. said it received certification that its device to destroy diseased tissue complies with an international standard of medical device safety, sending its shares up 13 percent.
PerkinElmer Pulls in $500 Million From Sales of IDS Unit
In its latest move of adding or subtracting business lines, PerkinElmer Inc. reports it has agreed to sell its Illumination and Detection Solutions (IDS) business to Veritas Capital Fund III LP, a New York-based private equity firm, for approximately $500 million in cash.
InfraReDx Gets OK to Market Imaging System
InfraReDx Inc. … said it has gotten a regulatory clearance to market a coronary imaging system.
Abbott Receives FDA Approval for Test to Assess Hepatitis B Treatment
Abbott announced Wednesday it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus in a patient’s blood.
Director of 510(k) Office Will Retire This Month
A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program.
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Devices & Diagnostics Letter
FDA Asking Devicemakers to Help With Overseas Supply Oversight
The FDA is trying to stretch its enforcement reach over foreign device suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the supply chain.
MEDEC: More Controls Needed on Reuse of Single-Use Devices
The reuse of single-use devices and an increase in user fees top the list of concerns the Canadian device industry is pushing the government to address in Health Canada’s fiscal 2011 budget.
Global Diagnostic Shortage Eases as Reactor Returns to Service
The makers of generators used to produce a commonly used diagnostic isotope are able to meet more of the global demand now that Canada’s National Research Universal (NRU) reactor is back online.
Director of 510(k) Office Will Retire Next Month
A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program.
Proposed Pre-Amendment Rule Should Have Little Impact
An FDA decision to classify four pre-amendment devices as Class III is expected to have little, if any, impact on the device industry.
Upcoming Meetings
Devicemakers Want More Clarity on Third-Party Audit Program
Devicemakers want more clarity on third-party audits by regulatory agencies in other countries, especially when it comes to possible enforcement actions.
J&J Quality Problems Spread to Some of Its Device Units
Johnson & Johnson (J&J), which has come under scrutiny recently for quality problems with its drug units, is starting to experience similar problems with its device companies.
FDA Expects to Publish an RFP Soon to Begin Developing UDI Database
After years of promises, the FDA says it plans to publish, within the next few months, a request for proposals (RFP) to begin the development and building of a unique device identifier (UDI) database.
Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in US
Trying to keep devicemakers, and the jobs they provide, in the U.S., two senators are urging the FDA to be more transparent and predictable in its review of 510(k)s.
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Medical Devices Today
Device Makers To Supreme Court: Investors Don't Need Adverse Event Reports Without Statistical Backing
Deals in Depth: July 2010
Ovesco Endoscopy AG
Changing Times Raise Barriers to Device Innovation
Stryker Completes Buyout Of Gaymar For $150 Million
Shuren's Center: FDA Device Chief Discusses Long Road To 510(k) Reform
FDA Targets Personalized Knee Surgery Systems With Warning Letters
Philips Contributes To $250 Million Venture Fund For Health-Tech Firms
The Artificial Disc Bust: Lessons Learned
Cadence, VCs Relieve J&J's Pain, Map Out A Clever Exit In The Process
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NuGeneration Technologies Corporate Headquarters: 1155 Park Avenue, Emeryville, CA 94608
Toll Free 888-996-8436, Phone 707-820-4080, Toll Free Fax (877) 204-9106, Fax 707-820-4079

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Gumlast®, FloDynamix®, SuperGreen®, and BioKlean® are Registered trade-marks of NuGeneration Technologies, LLC

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