PhotoFix Decellularized Bovine Pericardium

FDA UDI

Class II (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name: PhotoFix Decellularized Bovine Pericardium FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: Decellularized Bovine Pericardium FDA UDI
Model / Reference: PFP2X9 FDA UDI
Description: Decellularized Bovine Pericardium FDA UDI

Identifiers

Catalog Number: PFP2X9 FDA UDI
Primary DI / UDI-DI: 00877234000652 FDA UDI
FDA Product Code: PSQ FDA UDI
GMDN Term: Cardiovascular patch, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 2 Centimeter FDA UDI
Length — 9 Centimeter FDA UDI

Category: Cardiovascular patch, animal-derived

PhotoFix Decellularized Bovine Pericardium by Artivion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cardiovascular patch, animal-derived.

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Invengenx — Tisgenx · Class II
VascuCel — ADMEDUS REGEN PTY LTD · Class II
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II
XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Artivion, Inc.

Sources (1)

FDA UDI 3c6e0962-fbf9-4933-9c5d-5ee34936bfe3 37 fields · synced Jun 8, 2026