AccessGUDID - DEVICE: GORE PRECLUDE MVP Dura Substitute (00733132601462)

GUDID

Device Identifier (DI) Information

Brand Name: GORE PRECLUDE MVP Dura Substitute
Version or Model: 1MVP401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1MVP401
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132601462
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: MVP 5 CM X 6 CM

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?
58044	Dura mater graft, synthetic	A sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura; it is typically supplied in the form of a patch and may be sutured into place.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXQ	Dura Substitute

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 6 Centimeter
Width: 5 Centimeter

Device Record Status

Public Device Record Key: 4f065ab4-ee24-42e5-8a4a-b5123e584faf
Public Version Date: November 09, 2021
Public Version Number: 4
DI Record Publish Date: April 29, 2016