Supple Peri-Guard

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name: Supple Peri-Guard FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. FDA UDI
Model / Reference: SPG0608 FDA UDI
Description: SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. FDA UDI

Identifiers

Catalog Number: SPG0608 FDA UDI
Primary DI / UDI-DI: 00085412818313 FDA UDI
510(k) Number: K221029 FDA UDI
K223052 FDA UDI
FDA Product Code: FTM FDA UDI
PSQ FDA UDI
OXB FDA UDI
OWV FDA UDI
GMDN Term: Cardiovascular patch, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3300 FDA UDI
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

MRI Safety

MR Safe FDA UDI

Category: Cardiovascular patch, animal-derived

Supple Peri-Guard by Synovis Life Technologies, Inc. — 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
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
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II

Cleared under the same submission

K221029 also covers:

K223052 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: Synovis Life Technologies, Inc.

Sources (1)

FDA UDI fc2ebe37-77a6-46be-87c1-9c6cf44844c3 37 fields · synced Jun 6, 2026