Home GUDID 00190776392642 Millennium
Primary DI 00190776392642
Brand Millennium
Company Avalign Technologies, Inc.
Model 1-250191
Device description "Hibbs Gouge, 9 1/2"", curved, 3/8"""
Published 2025-05-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KAQ Gouge, Nasal, Ent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KAQ Gouge, Nasal, Ent Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776392642 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 00190776392642 00190776392642 190776392642 0190776392642
GMDN Terms# Term, Definition table Term Definition Surgical gouge A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). 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 00192896123007 Alexander Mastoid Gouge SONTEC INSTRUMENTS, INC. KAQ 2026-03-31 00757770498956 Bausch + Lomb Bausch & Lomb Incorporated KAQ 2025-08-01 G586E3871740 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3871750 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3871840 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3871850 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3871860 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3873730 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3873740 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3873750 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E3873770 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E7412240 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E7412490 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E7766960 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93871740 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93871760 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93873730 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93873740 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93873750 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E93873770 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E97412240 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 G586E97766960 Novo Surgical NOVO SURGICAL, INC. KAQ 2023-12-18 00842962147665 HNM MEDICAL HNM STAINLESS, LLC. KAQ 2023-04-07 00190776362232 Millennium Avalign Technologies, Inc. KAQ 2023-02-22 00190776362249 Millennium Avalign Technologies, Inc. KAQ 2023-02-22 00190776362256 Millennium Avalign Technologies, Inc. KAQ 2023-02-22 M6335143910 JEDMED JEDMED INSTRUMENT COMPANY KAQ 2023-02-03 00190776295189 Millennium Avalign Technologies, Inc. KAQ 2022-12-12 00190776295196 Millennium Avalign Technologies, Inc. KAQ 2022-12-12 00190776295202 Millennium Avalign Technologies, Inc. KAQ 2022-12-12
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