Home GUDID 00878953005898 AdVance
Primary DI 00878953005898
Brand AdVance
Company AMERICAN MEDICAL SYSTEMS, INC.
Model 1008380
Device description Male Sling
Published 2016-07-22
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OTM Mesh, Surgical, For Stress Urinary Incontinence, Male General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00878953005898 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 00878953005898 00878953005898 878953005898 0878953005898
GMDN Terms# Term, Definition table Term Definition Stress urinary incontinence surgical mesh, male A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (typically via transobturator approach) to support the urethra for the treatment of male stress urinary incontinence (SUI), usually resulting from prostate removal. It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.
Regulatory Flags# DUNS number 125111448 Device count 1 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 00191506003999 AdVance™ XP BOSTON SCIENTIFIC CORPORATION OTM 2022-03-21 08436568350882 Remeex System -Readjustment kit Long DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL OTM 2020-10-19 08436568350899 Male Remeex System - Thread Passer DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL OTM 2020-10-19 08437007606034 Male Remeex System DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL OTM 2020-10-19 08437007606232 Male Remeex System - Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL OTM 2020-10-19 08437007606836 Remeex System - Passer Handle DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL OTM 2020-10-19 00878953005560 AdVance™ XP BOSTON SCIENTIFIC CORPORATION OTM 2019-01-04 03760151650239 I-STOP TOMS CL MEDICAL OTM 2017-05-19 00878953005300 AdVance AMERICAN MEDICAL SYSTEMS, INC. OTM 2016-07-22 00878953005881 AdVance AMERICAN MEDICAL SYSTEMS, INC. OTM 2016-07-22 05708932499149 Virtue Coloplast A/S OTM 2015-10-22