AccessGUDID - DEVICE: GORE MYCROMESH PLUS Biomaterial (00733132601721)

GUDID

Device Identifier (DI) Information

Brand Name: GORE MYCROMESH PLUS Biomaterial
Version or Model: 1MYMP18
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1MYMP18
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132601721
Issuing Agency: GS1
Commercial Distribution End Date: January 15, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61423	Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063435	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 7.5 Centimeter
Length: 12 Centimeter
Height: 1 Millimeter

Device Record Status

Public Device Record Key: 8a03a5db-bf8e-4723-8255-28d8a7efda90
Public Version Date: October 21, 2020
Public Version Number: 4
DI Record Publish Date: March 07, 2016