CanGaroo Envelope

FDA UDI

Class II (US FDA UDI)

by Elutia Med LLC

Identity

Trade Name: CanGaroo Envelope FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators. FDA UDI
Model / Reference: CMCV-009-MED FDA UDI
Description: The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators. FDA UDI

Identifiers

Primary DI / UDI-DI: 00859389005034 FDA UDI
FDA Product Code: FTM FDA UDI
GMDN Term: Cardiovascular patch, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3300 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

MRI Safety

MR Safe FDA UDI

Category: Cardiovascular patch, animal-derived

CanGaroo Envelope by Elutia Med LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, animal-derived.

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VASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, 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

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: Elutia Med LLC

Sources (1)

FDA UDI 57d5b95b-c930-4af2-b513-7aada64c82b9 36 fields · synced May 30, 2026