Home GUDID 00857141005308 Quadra-Fuse Multi-Pronged Injection Needle
Primary DI 00857141005308
Brand Quadra-Fuse Multi-Pronged Injection Needle
Company Rex Medical LLP
Model 4518-15SS
Catalog number 4518-15SS
Published 2020-12-07
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 GAA Needle, Aspiration And Injection, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857141005308 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 00857141005308 00857141005308 857141005308 0857141005308
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.
Regulatory Flags# DUNS number 079535216 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857141005261 Quadra-Fuse Multi-Pronged Injection Needle 4218-10SS 4218-10SS 2020-12-07 00857141005278 Quadra-Fuse Multi-Pronged Injection Needle 4218-15SS 4218-15SS 2020-12-07 00857141005285 Quadra-Fuse Multi-Pronged Injection Needle 4218-20SS 4218-20SS 2020-12-07 00857141005292 Quadra-Fuse Multi-Pronged Injection Needle 4518-20SS 4518-20SS 2020-12-07 00857141005315 Quadra-Fuse Multi-Pronged Injection Needle 4518-10SS 4518-10SS 2020-12-07 10857141005251 Closer Vascular Sealing System 202704 202704 2017-03-28 00857141005001 OptionELITE Vena Cava Filter 352506070E 352506070E 2015-12-07 00857141005018 OptionELITE Vena Cava Filter, 100cm 352506100E 352506100E 2015-12-07
Other Devices Sharing Product Codes# 
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