Home GUDID 00842331191930 Novo Surgical Inc.
Primary DI 00842331191930
Brand Novo Surgical Inc.
Company NOVO SURGICAL, INC.
Model E8311-61
Device description "bruening tongue depressor, large, 7 1/2"" (19.0 cm)"
Published 2023-12-07
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 KBL Depressor, Metal Tongue, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842331191930 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 00842331191930 00842331191930 842331191930 0842331191930
GMDN Terms# Term, Definition table Term Definition Tongue depressor, surgical A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). 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 09348811004840 INKA The Trustee for KAISER FAMILY TRUST KBL 2025-11-25 09348811004970 INKA The Trustee for KAISER FAMILY TRUST KBL 2025-11-25 00190776407704 Millennium Avalign Technologies, Inc. KBL 2025-08-01 00190776407711 Millennium Avalign Technologies, Inc. KBL 2025-08-01 00194613046064 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-08-01 00194613049324 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-08-01 00194613049348 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-08-01 00194613049355 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-08-01 00194613049386 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-08-01 00194613049331 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-03-21 00194613107178 MSI Precision Specialty Instruments Med Saver, Inc. KBL 2025-03-21 00841036058838 N/A BIOMET MICROFIXATION, INC KBL 2024-09-25 00841036073350 N/A BIOMET MICROFIXATION, INC KBL 2024-09-25 00841036073367 N/A BIOMET MICROFIXATION, INC KBL 2024-09-25 00887482049150 Symmetry Andrew ASPEN SURGICAL PRODUCTS, INC. KBL 2024-08-15 00840183517243 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 00840183521714 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 00840183522858 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 00840183522865 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 00840183525422 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 00840183525736 BR Surgical, LLC BR Surgical, LLC KBL 2024-06-10 10381780538547 MicroFrance® INTEGRA MICROFRANCE KBL 2024-05-29 G586E831252ES0 Novo Surgical NOVO SURGICAL, INC. KBL 2023-12-18 G586E98312510 Novo Surgical NOVO SURGICAL, INC. KBL 2023-12-18 G586E98312520 Novo Surgical NOVO SURGICAL, INC. KBL 2023-12-18 G586E98313210 Novo Surgical NOVO SURGICAL, INC. KBL 2023-12-18 00190776049034 Avalign Avalign Technologies, Inc. KBL 2023-09-28 00190776049041 Avalign Avalign Technologies, Inc. KBL 2023-09-28 00190776290283 MILLENNIUM Avalign Technologies, Inc. KBL 2023-09-28 00190776326456 MILLENNIUM Avalign Technologies, Inc. KBL 2023-09-28
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