Home GUDID 00842331170294 Novo Surgical Inc.
Primary DI 00842331170294
Brand Novo Surgical Inc.
Company NOVO SURGICAL, INC.
Model E8221-71
Catalog number E8221-71
Device description adenotome blade for laforce & shambaugh adenotomes, 11.0 mm wide
Published 2022-11-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KBH Adenotome
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KBH Adenotome Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842331170294 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 00842331170294 00842331170294 842331170294 0842331170294
GMDN Terms# Term, Definition table Term Definition Orthopaedic osteotome A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle 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 033029433 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 00757770420322 Bausch + Lomb Bausch & Lomb Incorporated KBH 2025-07-29 00757770424443 Bausch + Lomb Bausch & Lomb Incorporated KBH 2025-07-29 00757770429974 Bausch + Lomb Bausch & Lomb Incorporated KBH 2025-07-29 00757770430055 Bausch + Lomb Bausch & Lomb Incorporated KBH 2025-07-29 00190776381943 Millennium Avalign Technologies, Inc. KBH 2024-04-30 G586E8221210 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221220 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221230 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221240 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221720 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221730 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 G586E8221740 Novo Surgical NOVO SURGICAL, INC. KBH 2023-12-18 00190776352721 Millennium Avalign Technologies, Inc. KBH 2023-11-17 00190776049430 Avalign Avalign Technologies, Inc. KBH 2023-09-28 00190776227999 Avalign Avalign Technologies, Inc. KBH 2023-09-28 00190776228002 Avalign Avalign Technologies, Inc. KBH 2023-09-28 00190776228019 Avalign Avalign Technologies, Inc. KBH 2023-09-28 00190776327194 Millennium Avalign Technologies, Inc. KBH 2023-06-23 G22313594910 Medetz Surgical Instruments Medetz Surgical Instruments LLC KBH 2023-06-08 00887482192825 Symmetry Surgical ASPEN SURGICAL PRODUCTS, INC. KBH 2022-12-08 00887482192832 Symmetry ASPEN SURGICAL PRODUCTS, INC. KBH 2022-12-08 00190660000103 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000110 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000127 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000134 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000141 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000158 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000165 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000172 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04 00190660000189 Ambler Surgical AMBLER SURGICAL CORP. KBH 2021-01-04
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