FDA.report

GORE MYCROMESH Biomaterial

Primary DI
00733132601561
Brand
GORE MYCROMESH Biomaterial
Company
W. L. Gore & Associates, Inc.
Model
1MYM10
Catalog number
1MYM10
Published
2016-03-07
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

Related Records

Contact Domains

Product Codes

CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications

CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00733132601561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132601561007331326015617331326015610733132601561

GMDN Terms

TermDefinition
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbableA sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes

TypeValueUnit
Height1Millimeter
Length19Centimeter
Width15Centimeter

Sterilization Methods

Method

Contacts

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
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

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00733132666997GORE® TAG® Thoracic Branch EndoprosthesisTAC123410ATAC123410A2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisTAC123710ATAC123710A2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisTAC124010ATAC124010A2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisTAC124510ATAC124510A2026-05-26
00733132663682GORE® VIABAHN® FORTEGRA Venous StentVNS100502A VNS100502A 2026-01-08
00733132663699GORE® VIABAHN® FORTEGRA Venous StentVNS240702AVNS240702A2026-01-08
00733132663705GORE® VIABAHN® FORTEGRA Venous StentVNS281502AVNS281502A2026-01-08
00733132663712GORE® VIABAHN® FORTEGRA Venous StentVNS281002AVNS281002A2026-01-08
00733132663729GORE® VIABAHN® FORTEGRA Venous StentVNS280702AVNS280702A2026-01-08
00733132663736GORE® VIABAHN® FORTEGRA Venous StentVNS280502AVNS280502A2026-01-08
00733132663743GORE® VIABAHN® FORTEGRA Venous StentVNS241502AVNS241502A2026-01-08
00733132663750GORE® VIABAHN® FORTEGRA Venous StentVNS241002AVNS241002A2026-01-08
00733132663767GORE® VIABAHN® FORTEGRA Venous StentVNS240502AVNS240502A2026-01-08
00733132663774GORE® VIABAHN® FORTEGRA Venous StentVNS201502AVNS201502A2026-01-08
00733132663781GORE® VIABAHN® FORTEGRA Venous StentVNS201002AVNS201002A2026-01-08
00733132663798GORE® VIABAHN® FORTEGRA Venous StentVNS200702AVNS200702A2026-01-08
00733132663804GORE® VIABAHN® FORTEGRA Venous StentVNS200502AVNS200502A2026-01-08
00733132663811GORE® VIABAHN® FORTEGRA Venous StentVNS181502AVNS181502A2026-01-08
00733132663828GORE® VIABAHN® FORTEGRA Venous StentVNS181002AVNS181002A2026-01-08

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