FDA.reportPublic FDA data

GORE BIO-A Tissue Reinforcement

Primary DI
H373FS20303
Brand
GORE BIO-A Tissue Reinforcement
Company
W. L. Gore & Associates, Inc.
Model
FS2030
Catalog number
FS2030
Device description
FLAT SHEET 20 X 30 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
OWZMesh, surgical, absorbable, thoracic, chest wall reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall ReconstructionGeneral, 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
00733132605453PrimaryGS10
H373FS20303SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132605453007331326054537331326054530733132605453

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
Length30Centimeter
Width20Centimeter

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
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644667GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644674GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644681GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644698GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644704GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644711GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132644728GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWZ2018-09-28
00733132605415GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132605422GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132605453GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132605439GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132605446GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132606139GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132606146GORE BIO-A Hernia PlugW. L. Gore & Associates, Inc.OWZ2017-02-13
00733132606153GORE BIO-A Hernia PlugW. L. Gore & Associates, Inc.OWZ2017-02-13