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GORE PRECLUDE Pericardial Membrane

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE PRECLUDE Pericardial Membrane FDA UDI
Generic Name
Pericardium prosthesis FDA UDI
Device Name
PCM 8.0 CM X 16.0 CM X 0.1 MM FDA UDI
Model / Reference
1PCM101 FDA UDI
Description
PCM 8.0 CM X 16.0 CM X 0.1 MM FDA UDI

Identifiers

Catalog Number
1PCM101 FDA UDI
Primary DI / UDI-DI
00733132601820 FDA UDI
510(k) Number
K012098 FDA UDI
FDA Product Code
DXZ FDA UDI
GMDN Term
Pericardium prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3470 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 8 Centimeter FDA UDI
Height — 0 Millimeter FDA UDI
Length — 16 Centimeter FDA UDI

GORE PRECLUDE Pericardial Membrane by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K012098 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 4a89a63b-b291-4819-89bf-dc79b07ab400 38 fields · synced May 30, 2026