FDA.reportPublic FDA data

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce

Primary DI
00733132600335
Brand
GORE SEAMGUARD Bioabsorbable Staple Line Reinforce
Company
W. L. Gore & Associates, Inc.
Model
BSGEC60AC
Catalog number
BSGEC60AC
Device description
BSGEC60 Anvil & Cartridge
Published
2017-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043056000GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.2004-12-22FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132600335PackageGS112Not in Commercial Distribution
00733132600809PackageGS11Not in Commercial Distribution
00733132627004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132600335007331326003357331326003350733132600335
00733132600809007331326008097331326008090733132600809
00733132627004007331326270047331326270040733132627004

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@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
true
Serial number
false
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
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntHPT040015AHPT040015A2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntHPT050005AHPT050005A2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntHPT050015AHPT050015A2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntHPT060015AHPT060015A2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntHPT350005AHPT350005A2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntHPT350015AHPT350015A2017-02-13
00733132607068GORE PROPATEN Vascular GraftIRH060545AIRH060545A2017-02-13
00733132607129GORE PROPATEN Vascular GraftIRH463845AIRH463845A2017-02-13
00733132607143GORE PROPATEN Vascular GraftIRH473845AIRH473845A2017-02-13
00733132653690GORE SYNECOR Preperitoneal BiomaterialGKWR4040GKWR40402022-11-08
00733132653706GORE SYNECOR Preperitoneal BiomaterialGKWR3030GKWR30302022-11-08
00733132653713GORE SYNECOR Preperitoneal BiomaterialGKWR4050GKWR40502022-11-08
00733132653720GORE SYNECOR Preperitoneal BiomaterialGKWR3535GKWR35352022-11-08
00733132653737GORE SYNECOR Preperitoneal BiomaterialGKWR3040GKWR30402022-11-08
00733132653744GORE SYNECOR Preperitoneal BiomaterialGKWC09GKWC092021-10-05
00733132605798GORE PROPATEN Vascular GraftH060010AH060010A2017-02-13
00733132605811GORE PROPATEN Vascular GraftH060040AH060040A2017-02-13
00733132605835GORE PROPATEN Vascular GraftH060060AH060060A2017-02-13
00733132605859GORE PROPATEN Vascular GraftH060080AH060080A2017-02-13
00733132605873GORE PROPATEN Vascular GraftH080040AH080040A2017-02-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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