Home GUDID 08717591240266 Macroplastique Implants
Primary DI 08717591240266
Brand Macroplastique Implants
Company Uroplasty, Inc.
Model MPQ-2.5
Catalog number MPQ-2.5
Device description Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Published 2014-06-20
Public version status Update
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 LNM Agent, Bulking, Injectable For Gastro-Urology Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08717591240266 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08717591240266 08717591240266 8717591240266
GMDN Terms# Term, Definition table Term Definition Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable A sterile, implantable, non-bioabsorbable synthetic material (e.g., hydrophilic polyacrylamide gel) intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR). It is in the form of a gel material typically preloaded in a disposable syringe and is implanted using an endoscope and/or other dedicated instruments.
Regulatory Flags# DUNS number 804002665 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08717591240167 Urgent® PC Neuromodulation System UPC 250 UPC 250 2016-09-19 08717591240228 Urgent® PC Neuromodulation System UPC 200 UPC 200 2016-09-19 08717591240273 Rigid Endoscopic Needle MRN-518 MRN-518 2016-09-22 08717591240280 Rigid Endoscopic Needle MRN-420 MRN-420 2016-09-22
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