Home GUDID H373FS080834 GORE BIO-A Tissue Reinforcement
Primary DI H373FS080834
Brand GORE BIO-A Tissue Reinforcement
Company W. L. Gore & Associates, Inc.
Model FS0808
Catalog number FS0808
Device description FLAT SHEET 8 X 8 CM - 1PK
Published 2017-02-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name OWT Mesh, surgical, absorbable, abdominal hernia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OWT Mesh, Surgical, Absorbable, Abdominal Hernia General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00733132605415 Primary GS1 0 H373FS080834 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00733132605415 00733132605415 733132605415 0733132605415
GMDN Terms# Term, Definition table Term Definition Multi-purpose surgical mesh, synthetic polymer, bioabsorbable A sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Length 8 Centimeter Width 8 Centimeter
Regulatory Flags# DUNS number 967358115 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true 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 00733132606290 GORE PROPATEN Vascular Graft Pediatric Shunt HPT040015A HPT040015A 2017-02-13 00733132606313 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050005A HPT050005A 2017-02-13 00733132606351 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050015A HPT050015A 2017-02-13 00733132606375 GORE PROPATEN Vascular Graft Pediatric Shunt HPT060015A HPT060015A 2017-02-13 00733132606399 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350005A HPT350005A 2017-02-13 00733132606436 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350015A HPT350015A 2017-02-13 00733132607068 GORE PROPATEN Vascular Graft IRH060545A IRH060545A 2017-02-13 00733132607129 GORE PROPATEN Vascular Graft IRH463845A IRH463845A 2017-02-13 00733132607143 GORE PROPATEN Vascular Graft IRH473845A IRH473845A 2017-02-13 00733132653690 GORE SYNECOR Preperitoneal Biomaterial GKWR4040 GKWR4040 2022-11-08 00733132653706 GORE SYNECOR Preperitoneal Biomaterial GKWR3030 GKWR3030 2022-11-08 00733132653713 GORE SYNECOR Preperitoneal Biomaterial GKWR4050 GKWR4050 2022-11-08 00733132653720 GORE SYNECOR Preperitoneal Biomaterial GKWR3535 GKWR3535 2022-11-08 00733132653737 GORE SYNECOR Preperitoneal Biomaterial GKWR3040 GKWR3040 2022-11-08 00733132653744 GORE SYNECOR Preperitoneal Biomaterial GKWC09 GKWC09 2021-10-05 00733132605798 GORE PROPATEN Vascular Graft H060010A H060010A 2017-02-13 00733132605811 GORE PROPATEN Vascular Graft H060040A H060040A 2017-02-13 00733132605835 GORE PROPATEN Vascular Graft H060060A H060060A 2017-02-13 00733132605859 GORE PROPATEN Vascular Graft H060080A H060080A 2017-02-13 00733132605873 GORE PROPATEN Vascular Graft H080040A H080040A 2017-02-13
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