AccessGUDID - DEVICE: GORE PRECLUDE Pericardial Membrane (00733132601837)

GUDID

Device Identifier (DI) Information

Brand Name: GORE PRECLUDE Pericardial Membrane
Version or Model: 1PCM102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1PCM102
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132601837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: PRECLUDE PERICARDIAL MEMBRANE 12.0cmX12.0cmX0.1mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
36182	Pericardium prosthesis	An implantable synthetic material intended to be used in the repair of the pericardium (the double membranous, cone-shaped fibroserous sac enclosing the heart and the roots of the great blood vessels).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012098	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
Length: 12 Centimeter
Height: 0 Millimeter
Width: 12 Centimeter

Device Record Status

Public Device Record Key: ef2d9748-6c68-4400-8fab-f40363ecb8b8
Public Version Date: December 25, 2023
Public Version Number: 7
DI Record Publish Date: February 13, 2017