GORE PRECLUDE Pericardial Membrane 1PCM001

GUDID H3731PCM00136

PCM 7.0CM X 10.0CM X 0.1MM

W. L. Gore & Associates, Inc.

Pericardium prosthesis

• Primary Device ID: H3731PCM00136
• NIH Device Record Key: e5456356-5af8-45f8-a3ac-6c3ed84b5151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE PRECLUDE Pericardial Membrane
• Version Model Number: 1PCM001
• Catalog Number: 1PCM001
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Height: 0 Millimeter
• Height: 0 Millimeter
• Height: 0 Millimeter
• Height: 0 Millimeter
• Height: 0 Millimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter
• Width: 7 Centimeter
• Length: 10 Centimeter
• Height: 0 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132601806 [Primary]
HIBCC	H3731PCM00136 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012098

FDA Product Code

• DXZ: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [GORE PRECLUDE Pericardial Membrane]

• H3731PCM10339: PCM 15.0 CM X 20.0 CM X 0.1 MM
• H3731PCM10238: PCM 12.0 CM X 12.0 CM X 0.1 MM
• H3731PCM10137: PCM 8.0 CM X 16.0 CM X 0.1 MM
• H3731PCM10036: PCM 6.0 CM X 12.0 CM X 0.1 MM
• H3731PCM00136: PCM 7.0CM X 10.0CM X 0.1MM