CardioCel 3D

FDA UDI

Class II (US FDA UDI)

by Admedus Regen Pty Ltd

Identity

Trade Name: CardioCel 3D FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: CardioCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture FDA UDI
Model / Reference: UC0406A FDA UDI
Description: CardioCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture FDA UDI

Identifiers

Catalog Number: C0406A FDA UDI
Primary DI / UDI-DI: 09348992000549 FDA UDI
510(k) Number: K170951 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

Yes

FDA UDI

Dimensions & Sizes

Size: Angle — 60 degree FDA UDI
Length — 6 Centimeter FDA UDI
Width — 4 Centimeter FDA UDI

Category: Cardiovascular patch, animal-derived

CardioCel 3D by Admedus Regen Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, animal-derived.

Biotronik BioEnvelope — Elutia Med LLC · Class II
XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
CardioCel Bioscaffold Patch 5 cm X 8 cm — LeMaitre Vascular, Inc. · Class II
VASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
Invengenx — Tisgenx · Class II
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II
XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II

Cleared under the same submission

K170951 also covers:

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: Admedus Regen Pty Ltd

Sources (1)

FDA UDI 50e9ad89-b498-4858-baa0-21165f339122 38 fields · synced May 30, 2026