Home GUDID 00857141005315 Quadra-Fuse Multi-Pronged Injection Needle
Primary DI 00857141005315
Brand Quadra-Fuse Multi-Pronged Injection Needle
Company Rex Medical LLP
Model 4518-10SS
Catalog number 4518-10SS
Published 2020-12-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 00857141005315 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 00857141005315 00857141005315 857141005315 0857141005315
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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00857141005308 Quadra-Fuse Multi-Pronged Injection Needle 4518-15SS 4518-15SS 2020-12-07 00857141005001 OptionELITE Vena Cava Filter 352506070E 352506070E 2015-12-07 00857141005018 OptionELITE Vena Cava Filter, 100cm 352506100E 352506100E 2015-12-07 10857141005251 Closer Vascular Sealing System 202704 202704 2017-03-28
Other Devices Sharing Product Codes# 
rexmedical.com