Home GUDID 00190660111793 Ambler Surgical
Primary DI 00190660111793
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Rumel tourniquet
Catalog number 45-687
Device description Rumel tourniquet, 12'', adult, 6.4mm flex neck, with ratchet
Published 2021-01-07
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 EYR TOURNIQUET, GASTRO-UROLOGY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EYR Tourniquet, Gastro-Urology General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660111793 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 00190660111793 00190660111793 190660111793 0190660111793
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, reusable A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 Device count 1 DM exempt true Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00190660100360 Ambler Surgical Fiberoptic light cable 40-800 2021-01-04 00190660100377 Ambler Surgical Fiberoptic light cable 40-500 2021-01-04 00190660100384 Ambler Surgical Fiberoptic light cable 40-810 2021-01-04 00190660100391 Ambler Surgical Fiberoptic light cable 40-505 2021-01-04 00190660100407 Ambler Surgical Fiberoptic light cable 40-820 2021-01-04 00190660100414 Ambler Surgical Fiberoptic light cable 40-830 2021-01-04 00190660100421 Ambler Surgical Fiberoptic light cable 40-510 2021-01-04 00190660100438 Ambler Surgical Fiberoptic light cable 40-515 2021-01-04 00190660100445 Ambler Surgical Fiberoptic light cable 40-520 2021-01-04 00190660100452 Ambler Surgical Fiberoptic light cable 40-525 2021-01-04 00190660100469 Ambler Surgical Fiberoptic light cable 40-530 2021-01-04 00190660100476 Ambler Surgical Fiberoptic light cable 40-535 2021-01-04 00190660100483 Ambler Surgical Fiberoptic light cable 40-840 2021-01-04 00190660100490 Ambler Surgical Fiberoptic light cable 40-850 2021-01-04 00190660100506 Ambler Surgical Fiberoptic light cable 40-860 2021-01-04 00190660100513 Ambler Surgical Fiberoptic light cable 40-540 2021-01-04 00190660100520 Ambler Surgical Fiberoptic light cable 40-600 2021-01-04 00190660100537 Ambler Surgical Fiberoptic light cable 40-610 2021-01-04 00190660100544 Ambler Surgical Fiberoptic light cable 40-100 2021-01-04 00190660100551 Ambler Surgical Fiberoptic light cable 40-620 2021-01-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00887482043622 Symmetry Rumel ASPEN SURGICAL PRODUCTS, INC. EYR 2024-08-12 00887482083857 Symmetry Rumel ASPEN SURGICAL PRODUCTS, INC. EYR 2024-08-12 00190776290498 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 00190776334734 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 00190776370060 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 14026704795670 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795694 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 54026704795678 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795700 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795687 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 54026704795692 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 00190776055837 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055844 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055868 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055875 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055882 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190660111786 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111809 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111816 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111823 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111830 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111847 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111854 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 10381780191018 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780191025 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780457862 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780457879 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 M2743055001 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 M2743055011 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 M2743054981 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02
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