FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWTMesh, surgical, absorbable, abdominal hernia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033671000GORE BIOABSORBABLE MESHW. L. Gore & Associates, Inc.2003-12-31OWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132605415PrimaryGS10
H373FS080834SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132605415007331326054157331326054150733132605415

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
Length8Centimeter
Width8Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)528-8763mpdcustomercare@wlgore.com

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 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
00801741226519PhasixDavol Inc.OWT2025-02-24
00801741226533PhasixDavol Inc.OWT2025-02-24
00801741226571PhasixDavol Inc.OWT2025-02-24
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
00860006566708BioBrace 5mmBiorez, Inc.OWT2021-05-24
00801741161247PhasixDavol Inc.OWT2019-08-16
00801741161292PhasixDavol Inc.OWT2019-08-16
00801741161216PhasixDavol Inc.OWT2019-07-12
00801741161223PhasixDavol Inc.OWT2019-07-12
00801741161230PhasixDavol Inc.OWT2019-07-12
00801741161254PhasixDavol Inc.OWT2019-07-12
00801741161261PhasixDavol Inc.OWT2019-07-12
00801741161278PhasixDavol Inc.OWT2019-07-12
00801741161285PhasixDavol Inc.OWT2019-07-12
00801741161308PhasixDavol Inc.OWT2019-07-12
00801741163173PhasixDavol Inc.OWT2019-06-19
00801741163197PhasixDavol Inc.OWT2019-06-19
00801741163203PhasixDavol Inc.OWT2019-06-19