Home GUDID 10649111134012 Sklar
Primary DI 10649111134012
Brand Sklar
Company SKLAR CORPORATION
Model 78-3460
Device description LABORDE TRACH DILTR 3PRG 5 1/2
Published 2019-03-13
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 KCG DILATOR, TRACHEAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KCG Dilator, Tracheal Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10649111134012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10649111134012 10649111134012
GMDN Terms# Term, Definition table Term Definition Tracheal surgery dilator, reusable A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 006966006 Device count 1 Premarket exempt true Lot or batch true Serial number true No natural rubber latex 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 00190776399351 Millennium Avalign Technologies, Inc. KCG 2025-05-30 04049047041818 Gimmi Gimmi GmbH KCG 2025-05-08 04049047700043 Gimmi Gimmi GmbH KCG 2025-05-08 G043280420 BEAR Bear-Ent, LLC KCG 2024-08-03 00840183513764 BR Surgical, LLC BR Surgical, LLC KCG 2024-06-10 00888515246850 BOSS Instruments BOSS INSTRUMENTS, LTD., INC. KCG 2024-02-28 00888515246867 BOSS Instruments BOSS INSTRUMENTS, LTD., INC. KCG 2024-02-28 00888515246881 BOSS Instruments BOSS INSTRUMENTS, LTD., INC. KCG 2024-02-28 G586E98477130 Novo Surgical NOVO SURGICAL, INC. KCG 2023-12-18 G25010005140 Laborde Dilator Forcep N S SURGICAL COMPANY KCG 2023-04-29 00842331179754 Novo Surgical Inc. NOVO SURGICAL, INC. KCG 2022-11-14 00842331160448 Novo Surgical Inc. NOVO SURGICAL, INC. KCG 2022-11-13 00842331139123 Novo Surgical Inc. NOVO SURGICAL, INC. KCG 2022-11-11 00842331136054 Novo Surgical Inc. NOVO SURGICAL, INC. KCG 2022-11-10 00887482049303 Symmetry Trousseau ASPEN SURGICAL PRODUCTS, INC. KCG 2022-10-13 00887482049310 Symmetry Laborde ASPEN SURGICAL PRODUCTS, INC. KCG 2022-10-13 00887482124123 Symmetry Trousseau ASPEN SURGICAL PRODUCTS, INC. KCG 2022-10-13 00887482124130 Symmetry Laborde ASPEN SURGICAL PRODUCTS, INC. KCG 2022-10-13 00887482002322 Symmetry Delaborde ASPEN SURGICAL PRODUCTS, INC. KCG 2022-09-07 00887482002605 Symmetry Trousseau ASPEN SURGICAL PRODUCTS, INC. KCG 2022-09-07 00190776184469 Millennium Avalign Technologies, Inc. KCG 2021-11-01 00190776184476 Millennium Avalign Technologies, Inc. KCG 2021-11-01 04035324017263 TRACOE experc Dilation Set Tracoe medical GmbH KCG 2021-03-05 04046826135782 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft KCG 2020-09-24 04046826135799 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft KCG 2020-09-24 04046826135805 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft KCG 2020-09-24 10649111117039 Sklar SKLAR CORPORATION KCG 2019-03-13 10649111397165 Sklar SKLAR CORPORATION KCG 2019-03-13 10649111397172 Sklar SKLAR CORPORATION KCG 2019-03-13 10381780086499 Integra® INTEGRA LIFESCIENCES PRODUCTION CORPORATION KCG 2018-10-24