GORE PRECLUDE Pericardial Membrane

Basic Information

• Brand Name: GORE PRECLUDE Pericardial Membrane
• Primary DI: 00733132601820
• Version / Model: 1PCM101
• Catalog Number: 1PCM101
• Company Name: W. L. Gore & Associates, Inc.
• Labeler DUNS: 967358115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 4a89a63b-b291-4819-89bf-dc79b07ab400

Device Description

PCM 8.0 CM X 16.0 CM X 0.1 MM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H3731PCM10137	HIBCC
Primary	00733132601820	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K012098	000

Device Sizes

Type	Value	Unit	Text
Width	8	Centimeter
Height	0	Millimeter
Length	16	Centimeter