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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 J&J Looks to Emerging Markets Amid Soft U.S. Sales
Johnson & Johnson (J&J) is looking to emerging markets and diabetes care to propel future sales of devices and diagnostics, company executives said in a Jan. 24 earnings call.EC Seeks More Data on PIP Implants, Plans to Ramp up Device Vigilance
Devicemakers across the EU should brace themselves for increased surveillance by competent authorities, including unannounced inspections, additional testing of products already on the market and heightened controls of notified bodies, the European Commission said following receipt of a “rapid scientific opinion” on the safety of faulty silicone breast implants.China Department of Health Issues User Guide Device Alert
The Chinese Department of Health has issued a field safety notice for Abbott Molecular’s Bar Code Scanner user’s guide.Democrats Want to Let FDA Block Medical Devices Tied to Safety Recalls
U.S. regulators should be able to block medical devices based on past products with safety issues, said House Democrats, citing injuries from transvaginal implants like those made by Johnson & Johnson and C.R. Bard.Breast Implant Fears Spark Brussels Crackdown
The European Commission said it would toughen the regulation of medical devices as a result of concerns raised by breast implants produced by the defunct French company PIP, even as a scientific expert review it ordered concluded there was currently “insufficient evidence” that women using its products faced greater health risks than others.Charges Dropped Against Former Stryker Biotech President
Federal prosecutors dropped all charges against former Stryker Biotech president Mark Philip in a lawsuit charging him and a clutch of sales reps with illegally promoting the off-label use of two bone growth products and of lying to the FDA.New Toshiba Aquilion Prime CT Cleared by FDA
The Food and Drug Administration has cleared the latest CT scanner in Toshiba America Medical System’s Aquilion line.Dry Eye Treatment From TearScience Gets FDA 510(k) Clearance
Medical device company TearScience has received 510(k) clearance on the latest version of its evaporative dry eye treatment.RSS integration by RSSinclude
Devices & Diagnostics Letter AdvaMed: MDUFA Agreement Could Be “Game Changer” for FDA, Industry
A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said.Delays in MDUFA Agreement Threaten Omnibus User Fee Bill
Rather than breaking device user fees out of an omnibus bill, House Energy & Commerce Health Subcommittee Chair Joe Pitts (R-Pa.) reportedly has threatened to freeze device fees at current levels for five years if the FDA and industry can’t speed up an agreement on Medical Device User Fee Act (MDUFA) reauthorization.GAO: Lack of Transparency in Hospital Device Purchasing
Hospitals may be overpaying for implantable medical devices and passing those costs on to Medicare, but it is impossible to know for certain because Medicare doesn’t track device prices or what hospitals pay for them, a Government Accountability Office (GAO) report concludes.Fired FDAers Sue for Email Monitoring: Senator Moves for Probe of FDA
A lawsuit that charges the FDA with monitoring the personal email of former CDRH employees has sparked a congressional probe and prompted fears among legal experts, who say the FDA’s actions could have a chilling effect on other whistleblowers.Devicemakers May Have Some Protection in Reprocessed Failures
Manufacturers whose devices are reprocessed and later cause injury may have some liability protection, a recent federal court case evaluated by the Washington Legal Foundation (WLF) suggests.Heart Valve Replacement Results Improve in Ongoing TAVR Trial
Strong clinical trial results from an add-on study of Edwards Lifesciences’ Sapien transcatheter aortic valve replacement (TAVR) bode well for the company and the fledgling TAVR segment generally, analysts say.FDA Outlines Steps to Improve Public Access to Compliance Data
Speeding data disclosure is just one of eight proposals FDA Commissioner Margaret Hamburg is adopting as part of efforts to improve public access to compliance and enforcement data.Bill Could Bar Devices Tied to Unsafe Predicates
Devicemakers could have a more limited body of predicates to use in submitting 510(k) applications under legislation now before the House Committee on Energy and Commerce.RSS integration by RSSinclude