Home GUDID 08714729845256 Polyform™
Primary DI 08714729845256
Brand Polyform™
Company BOSTON SCIENTIFIC CORPORATION
Model M0068402590
Device description Synthetic Mesh
Published 2015-09-24
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 OTO Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08714729845256 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729845256 08714729845256 8714729845256
GMDN Terms# Term, Definition table Term Definition Pelvic organ prolapse surgical mesh, synthetic polymer A sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 021717889 Device count 1 Lot or batch 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 00890594000056 Desara Blue SL Caldera Medical, Inc. OTO 2022-08-03 00890594000070 Desara Blue SL Caldera Medical, Inc. OTO 2022-08-03 10705031202795 ARTISYN Johnson & Johnson Medical GmbH OTO 2019-01-29 00890594000339 Vertessa Lite 10x22cm Caldera Medical, Inc. OTO 2016-05-27 00890594000391 Vertessa Lite Strips 4x22cm Caldera Medical, Inc. OTO 2016-05-27 00890594000452 Vertessa Lite Y 22x5x4cm Caldera Medical, Inc. OTO 2016-05-27 00890594000704 Desara Blue OV Caldera Medical, Inc. OTO 2016-05-27 00890594000735 Desara Blue Short Suture Sling Caldera Medical, Inc. OTO 2016-05-27 00890594000643 Vertessa Lite 10x22cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000360 Vertessa Lite 10x26cm Caldera Medical, Inc. OTO 2016-05-27 00890594000384 Vertessa Lite Strips 4x22cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000421 Vertessa Lite Y-mesh 22x4x3cm Caldera Medical, Inc. OTO 2016-05-27 00890594000445 Vertessa Lite Y 22x5x4cm CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000766 Desara SL Caldera Medical, Inc. OTO 2016-05-27 00890594000698 Desara Blue OV CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000728 Desara Blue Short Suture Sling CALDERA MEDICAL, INC. OTO 2016-05-27 00089059400766 Desara SL CALDERA MEDICAL, INC. OTO 2016-05-27 00890594000674 Desara Blue Caldera Medical, Inc. OTO 2016-05-26 00890594000797 Vertessa Lite Y-Mesh 26x5x4cm Caldera Medical, Inc. OTO 2015-10-30 00890594000483 Vertessa Lite Y-Mesh 26x4x3cm Caldera Medical, Inc. OTO 2015-10-30 00890594000773 Vertessa Lite Y-Mesh 26x5x4cm CALDERA MEDICAL, INC. OTO 2015-10-30 05708932483223 Restorelle Coloplast A/S OTO 2015-10-24 00814723020333 IntePro Y-Mesh ENDO PHARMACEUTICALS INC. OTO 2015-10-24 05708932483285 Restorelle Coloplast A/S OTO 2015-10-22 05708932483834 Restorelle Coloplast A/S OTO 2015-10-22 05708932483896 Restorelle Coloplast A/S OTO 2015-10-22 05708932483964 Restorelle Coloplast A/S OTO 2015-10-22 05708932528108 Restorelle Coloplast A/S OTO 2015-10-22 05708932553773 Coloplast Coloplast A/S OTO 2015-10-22 08714729839217 Upsylon™ BOSTON SCIENTIFIC CORPORATION OTO 2015-09-24