← Back to catalogue

CardioGRAFT-MC™

FDA UDI

Class II (US FDA UDI)

by Lifenet Health

Identity

Trade Name
CardioGRAFT-MC™ FDA UDI
Generic Name
Cadaveric pulmonary artery bioprosthesis FDA UDI
Device Name
Decell Pulmonary Patch - Thick FDA UDI
Model / Reference
DPPGK5520 FDA UDI
Description
Decell Pulmonary Patch - Thick FDA UDI

Identifiers

Catalog Number
DPPGK5520 FDA UDI
Primary DI / UDI-DI
00889858013192 FDA UDI
FDA Product Code
DXZ FDA UDI
GMDN Term
Cadaveric pulmonary artery bioprosthesis 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

No

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

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Width — 20 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Cadaveric pulmonary artery bioprosthesis

CardioGRAFT-MC™ by Lifenet Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cadaveric pulmonary artery bioprosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lifenet Health

Sources (1)

  • FDA UDI 7331d3f2-3017-4015-84b4-26bebdb2b441 36 fields · synced May 31, 2026