GORE MYCROMESH PLUS Biomaterial

Primary DI
00733132601622
Brand
GORE MYCROMESH PLUS Biomaterial
Company
W. L. Gore & Associates, Inc.
Model
1MYMP02
Catalog number
1MYMP02
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
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
K063435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063435000GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIALW. L. Gore & Associates, Inc.2006-11-28FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132601622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132601622007331326016227331326016220733132601622

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobialA sterile, flat or three-dimensional (3-D), woven/knitted material made of non-bioabsorbable synthetic polymer(s) intended for multiple defective tissue repair applications at different anatomical zones (e.g., thoracic, abdominal) that includes an extra-abdominal application(s); it includes a pharmaceutical antibacterial substance/agent (e.g., chlorhexidine diacetate). It may also be used as a scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Millimeter
Length15Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005288763mpdcustomercare@wlgore.com

Regulatory Flags#

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

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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