Home GUDID 00190776042370 Avalign
Primary DI 00190776042370
Brand Avalign
Company Avalign Technologies, Inc.
Model VM101-8197
Device description Farrior Speculum, Size 4 Round Oblique
Published 2023-11-13
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 EPY SPECULUM, ENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EPY Speculum, Ent General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776042370 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 00190776042370 00190776042370 190776042370 0190776042370
GMDN Terms# Term, Definition table Term Definition Ear speculum, reusable A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. 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 00840329837457 N/A BLACK & BLACK SURGICAL, INC. EPY 2026-03-05 G04360200G0 GEIZ Bear-Ent, LLC EPY 2026-03-05 G04360201G0 GEIZ Bear-Ent, LLC EPY 2026-03-05 G04360202G0 GEIZ Bear-Ent, LLC EPY 2026-03-05 G04360203G0 GEIZ Bear-Ent, LLC EPY 2026-03-05 G04360204G0 GEIZ Bear-Ent, LLC EPY 2026-03-05 00840329837464 N/A BLACK & BLACK SURGICAL, INC. EPY 2026-03-04 00198506088414 ELMED INCORPORATED ELMED INCORPORATED EPY 2026-02-23 00810158218925 PRINCETON Princeton Medical Group, Inc. EPY 2026-02-16 00190776415846 Millennium Avalign Technologies, Inc. EPY 2026-02-04 G383WM7778700 SURJEX SURJEX EPY 2026-01-31 G383WM7778701 SURJEX SURJEX EPY 2026-01-31 G383WM7778702 SURJEX SURJEX EPY 2026-01-31 G383WM7778703 SURJEX SURJEX EPY 2026-01-31 04050659354647 Brünings anastignatic aural magnifier Spiggle & Theis Medizintechnik GmbH EPY 2026-01-21 00810158218437 PRINCETON Princeton Medical Group, Inc. EPY 2026-01-07 00810158218444 PRINCETON Princeton Medical Group, Inc. EPY 2026-01-07 09348811116314 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811116321 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811116352 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811116376 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811116390 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811148865 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-02 09348811116574 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811116628 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811116772 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811116789 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811116895 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811116901 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01 09348811117083 INKA The Trustee for KAISER FAMILY TRUST EPY 2025-12-01
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