FDA.reportPublic FDA data

GORE ENFORM Preperitoneal Biomaterial

Primary DI
00733132644629
Brand
GORE ENFORM Preperitoneal Biomaterial
Company
W. L. Gore & Associates, Inc.
Model
GBWR2025
Catalog number
GBWR2025
Device description
ENFORM PREPERITONEAL 20cmX25cm Biomaterial
Published
2018-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWTMesh, Surgical, Absorbable, Abdominal Hernia
OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2
OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall ReconstructionGeneral, Plastic Surgery2
OXCMesh, Surgical, Absorbable, Staple Line ReinforcementGeneral, Plastic Surgery2
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173333000GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.2018-04-05OXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132644629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132644629007331326446297331326446290733132644629

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbableA 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
TypeValueUnit
Length20Centimeter
Width25Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132658855GORE® DrySeal Flex Introducer SheathGDSF1033GDSF10332024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathGDSF1045GDSF10452024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathGDSF1065GDSF10652024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathGDSF1133GDSF11332024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathGDSF1233GDSF12332024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathGDSF1245GDSF12452024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathGDSF1265GDSF12652024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathGDSF1433GDSF14332024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathGDSF1465GDSF14652024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathGDSF1533GDSF15332024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathGDSF1633GDSF16332024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathGDSF1665GDSF16652024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathGDSF1833GDSF18332024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathGDSF1865GDSF18652024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathGDSF2033GDSF20332024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathGDSF2065GDSF20652024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathGDSF2233GDSF22332024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathGDSF2265GDSF22652024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathGDSF2433GDSF24332024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathGDSF2465GDSF24652024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332999000222TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000239TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000246TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000468TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000475TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
04548366322450NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322467NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322474NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322498NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322504NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322511NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322528NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322535NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322542NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322559NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830313NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830337NEOVEILGUNZE LIMITEDOXC2025-04-21
00801741226519PhasixDavol Inc.OWT2025-02-24
00801741226533PhasixDavol Inc.OWT2025-02-24
00801741226571PhasixDavol Inc.OWT2025-02-24
00851677007140Atlas SSLR Buttress AssemblySTANDARD BARIATRICS, INCOXC2024-07-10
10884521809703TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809710TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809727TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809734TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10653405988946BioBraceConmed CorporationOWT2024-02-12
10653405988939BioBraceConmed CorporationOWT2024-02-12
10653405988953BioBraceConmed CorporationOWT2024-02-12
10653405988960BioBraceConmed CorporationOWT2024-02-12
04973077713776NEOVEILGUNZE LIMITEDOXC2023-03-27