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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:
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PRODUCTS OFFERED (click on name for tech data sheets) |
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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.
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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). |
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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. |
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| Formulated Sulfamic Acid Cleaners: Acid Cleaning compound. Sulfamic acid based. | |||||||||
| Nitric Acid: Concentrations of Nitric acid from 1% to 70%. Available in 500ml bottles to drum quantities. Coronary nitric acid. | |||||||||
| Nitric Acid & HF Blends: Nitric and Hydrofluoric Acid. Many ratios available. Please call or email for more information. | |||||||||
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i. NuGenTec EP 316 - Electro Polishing
ii. NuWet DM 41 Alkaline Medical Device & Electronics grade Cleaning Compound
FDAnews Device Daily Bulletin Australia Approves Regulations, Classifications for IVD Devices
All in vitro diagnostic (IVD) devices must undergo a risk-based level of review before they can be marketed in Australia beginning July 1.Devicemakers Ask FDA to Rethink One-Click Links to Safety Info
Industry is asking the FDA to reconsider its apparent rejection of a “one-click” policy for presenting device safety information in some online messages, a practice that prompted 14 untitled letters last year.TB Diagnostics to Be Discussed at Workshop
The FDA and other HHS agencies will hold a public workshop June 7 and 8 in Silver Spring, Md., on ways to advance the development of diagnostic tests and biomarkers for tuberculosis (TB).Nipro, Home Diagnostics Complete Tender Offer
Nipro Corporation and Home Diagnostics, Inc. announced the successful completion of the offer to purchase all outstanding shares of the common stock of Home Diagnostics, Inc. by Nipro’s wholly-owned subsidiary, Nippon Product Acquisition Corporation.Guidelines: Do Medical Tests Later, Less Often
Recent reports and guideline changes suggest some medical tests should be delayed, avoided, or done less often:Volcano Expands Access to FFR
Volcano Corporation, a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced its Fractional Flow Reserve (FFR) technology can now integrate with the FFR modules of hemodynamic monitoring systems from GE, Siemens, McKesson, and Mennen.Medtronic Starts International Study of Transcatheter Aortic Valve System
Moving to expand the evidence base for the future of structural heart disease therapy, Medtronic, Inc., announced the start of the first of several new initiatives in a robust international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.Bovie Medical Cleared to Market ICON VS Electrosurgical Generator
Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, announced the Company received clearance from the Food and Drug Administration to market its ICON VS electrosurgical generator.Sorin Group Reaches Tentative Settlement With Department of Justice
Sorin Group, a global company and a leader in the treatment of cardiovascular diseases, announced that it has reached a tentative settlement of the previously disclosed 2006 United States Department of Justice investigation into sales and marketing practices of its subsidiary Ela Medical Inc. and of former independent sales representatives.Abbott Molecular Gets 483 Listing Six Observations
Abbott Molecular’s Des Plaines, Ill., facility received six observations related to its hepatitis B virus (HBV) in vitro diagnostic.RSS integration by RSSinclude
Devices & Diagnostics Letter Briefs Guidewire Technologies Cited for Sterilization, Audit Issues
Guidewire Technologies received a warning letter for not following sterilization procedures, adequately validating processes and conducting quality audits.FDA Cites Biological Controls for QS, Documentation Issues
Biological Controls has been warned for several quality system (QS) and documentation failures, including failure to establish a quality policy or audit procedures.Device Supply Chain Ethics Consideration in the UK
A campaign launched by the British Medical Association (BMA) pressuring the National Health Service (NHS) to only purchase surgical instruments that are ethically manufactured should have devicemakers scrutinizing their supply chain.FDA Seeks Industry Comment on Transparency Project
The FDA has set an April 12 deadline for feedback on what the agency should do to improve communication and guidance development with manufacturers.CDRH: Rule on UDI Database Close to Becoming Reality
CDRH expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011.CDRH to Turn to Global Standards to Aid in Regulatory Consistency
“Standards” will become the new watchword at CDRH as the center seeks regulatory alternatives to guidances and advisory panels and strives for more consistency in its processes.FDA Approves Alternate Source for Widely Used Diagnostic
To help ease the global shortage of technetium 99m (Tc-99m), the most widely used diagnostic isotope, the FDA and Health Canada have approved an alternate source in Poland.510(k) Process Bogging Down in Review Delays at CDRH
Even though CDRH is meeting its goals in making decisions on device clearances, some devicemakers are waiting years to hear if their products have been cleared.Patent Reform Bill Amendment Tightens Willfulness Standards
Devicemakers would have to use specific examples to prove competitors have willfully violated their patents under an amendment to the Patent Reform Act of 2009.RSS integration by RSSinclude