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