Home GUDID 00190776051501 Avalign
Primary DI 00190776051501
Brand Avalign
Company Avalign Technologies, Inc.
Model VM57-3711
Device description Doyen Tumor Screw,
Published 2021-11-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GAD RETRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776051501 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 00190776051501 00190776051501 190776051501 0190776051501
GMDN Terms# Term, Definition table Term Definition Myoma screw, reusable A hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. 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 00198506091926 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506092015 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506093685 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00841731153104 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 00841731153111 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 B8038600980 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038600990 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803860120L0 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038601250 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018420 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018430 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018840 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039030020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039401000 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601360 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601370 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601390 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601400 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803NL97010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803NL9701H0 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 00190776402174 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403317 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403324 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403362 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00840183532185 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532192 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532222 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532239 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21
avalign.com