Home GUDID 00190776234447 Avalign
Primary DI 00190776234447
Brand Avalign
Company Avalign Technologies, Inc.
Model VM2116426
Device description Suture Retriever Cone Guide, TW 10mm, 2
Published 2023-09-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HCF INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776234447 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 00190776234447 00190776234447 190776234447 0190776234447
GMDN Terms# Term, Definition table Term Definition Suturing unit, reusable A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch true 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 04058749121087 NA Fehling Instruments GmbH & Co. KG HCF 2026-03-05 00198506088223 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-01-27 00198506088162 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-01-22 00198506088179 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-01-22 00198506087660 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-01-16 00198506087776 ELMED INCORPORATED ELMED INCORPORATED HCF 2026-01-16 00848657077989 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. HCF 2026-01-13 00848657077996 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. HCF 2026-01-13 10850012846519 C1® DEPTH LIMITER LSI Solutions, Inc. HCF 2025-12-08 04058749118711 NA Fehling Instruments GmbH & Co. KG HCF 2025-12-08 00190776411916 Millennium Avalign Technologies, Inc. HCF 2025-09-25 00840217909952 Wiggins medical Ebner Medical, LLC HCF 2025-09-17 00198506085581 ELMED INCORPORATED ELMED INCORPORATED HCF 2025-09-12 00198506085024 ELMED INCORPORATED ELMED INCORPORATED HCF 2025-09-05 00198506084812 ELMED INCORPORATED ELMED INCORPORATED HCF 2025-08-26 G4533352105310 PEAK MEDICAL Peak Medical Distribution Inc. HCF 2025-08-13 00194613009137 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009151 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009168 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009182 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009205 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009229 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009236 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009243 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009267 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009274 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613009298 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613039493 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613039516 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01 00194613051181 MSI Precision Specialty Instruments Med Saver, Inc. HCF 2025-08-01
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