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CardioWrap®

FDA UDI

Class II (US FDA UDI)

by Mast Biosurgery Usa Inc.

Identity

Trade Name
CardioWrap® FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used as a pericardium replacement device in patients that may require re-operation within six months. FDA UDI
Model / Reference
130 x 200 x 0.05mm FDA UDI
Description
Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used as a pericardium replacement device in patients that may require re-operation within six months. FDA UDI

Identifiers

Catalog Number
36504-01 FDA UDI
Primary DI / UDI-DI
08964050365040 FDA UDI
510(k) Number
K031785 FDA UDI
FDA Product Code
OMH FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 200 Millimeter FDA UDI
Width — 130 Millimeter FDA UDI

CardioWrap® by Mast Biosurgery Usa Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K031785 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mast Biosurgery Usa Inc.

Sources (1)

  • FDA UDI 91d97f19-518b-4147-8e6b-3b764afa838a 39 fields · synced Jun 8, 2026