Home GUDID 00827002537408 Cook
Primary DI 00827002537408
Brand Cook
Company COOK INCORPORATED
Model G53740
Catalog number MIN-241625
Device description Multi-Injection Needle
Published 2020-10-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FHR NEEDLE, GASTRO-UROLOGY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FHR Needle, Gastro-Urology General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00827002537408 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 00827002537408 00827002537408 827002537408 0827002537408
GMDN Terms# Term, Definition table Term Definition Multiple-pronged submucosal injection needle An instrument in the form of a needle with multiple sharp prongs intended to be used in conjunction with a syringe to administer a multiple-site injection into the submucosal layer of tissue, typically of anatomical structures with lumens. It includes a retractable proximal handle to manually deploy and position the needle in the target tissue, and is often used to inject substances (e.g., cell therapy preparations) into urethral tissues [e.g., mid-urethral tissue, external urethral sphincter], typically for treating female stress urinary incontinence (SUI). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place.
Regulatory Flags# DUNS number 042823948 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00757770413867 Bausch + Lomb Bausch & Lomb Incorporated FHR 2025-08-18 00757770425150 Bausch + Lomb Bausch & Lomb Incorporated FHR 2025-08-18 10810235030638 "Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)" MERZ NORTH AMERICA, INC. FHR 2024-10-21 00190776329549 MILLENNIUM Avalign Technologies, Inc. FHR 2023-09-28 00190776248659 Avalign Avalign Technologies, Inc. FHR 2023-06-23 14026704791665 PILLING TELEFLEX INCORPORATED FHR 2022-12-08 54026704791663 PILLING TELEFLEX INCORPORATED FHR 2022-12-08 00827002145191 Cook COOK INCORPORATED FHR 2020-10-02 10885403205293 V. Mueller STERIS CORPORATION FHR 2018-09-17 10885403205309 V. Mueller STERIS CORPORATION FHR 2018-09-17 10885403205316 V. Mueller STERIS CORPORATION FHR 2018-09-17 10885403050725 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050732 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050336 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050343 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050350 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050121 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30 10885403050138 V. Mueller CAREFUSION 2200, INC FHR 2018-08-30
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