Home GUDID 00190776436544 Millenium
Primary DI 00190776436544
Brand Millenium
Company Avalign Technologies, Inc.
Model 85-25008250
Device description Ergo Needleholder, TC, with port, straight, squeeze handle, WL 450mm (17 3/4"), OL 650mm (25 5/8")
Published 2026-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776436544 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776436544 00190776436544 190776436544 0190776436544
GMDN Terms# Term, Definition table Term Definition Suturing needle holder, reusable A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776436186 Millennium Avalign Technologies, Inc. GEI 2026-10-08 00190776436599 Millenium Avalign Technologies, Inc. GEI 2026-10-08 00840096215380 Disposable Bipolar Forceps, 8", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-08 00848657078504 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657078511 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657078528 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657083805 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00848657083904 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-08 00840096215335 Disposable Bipolar Forceps, 7", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215342 Disposable Bipolar Forceps, 7", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215359 Disposable Bipolar Forceps, 7", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215366 Disposable Bipolar Forceps, 8", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215373 Disposable Bipolar Forceps, 8", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215397 Disposable Bipolar Forceps, 9", 0.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215403 Disposable Bipolar Forceps, 9", 1.0mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00840096215410 Disposable Bipolar Forceps, 9", 1.5mm Straight Tips KATALYST SURGICAL LLC GEI 2026-10-07 00190776434328 Millennium Avalign Technologies, Inc. GEI 2026-10-06 B382SD134188100 Surgical Direct Surgical Direct, Inc. GEI 2026-10-06 B382SD13798330 Surgical Direct Surgical Direct, Inc. GEI 2026-10-06 00190776433284 Millennium Avalign Technologies, Inc. GEI 2026-10-05 00848657078467 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657078474 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083782 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083812 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083843 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083874 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657083898 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657084956 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657084963 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05 00848657084970 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GEI 2026-10-05
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