Biotronik BioEnvelope

FDA UDI

Class II (US FDA UDI)

by Elutia Med LLC

Identity

Trade Name: Biotronik BioEnvelope FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. FDA UDI
Model / Reference: 440578 FDA UDI
Description: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 04035479160548 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

Dimensions & Sizes

Size: Width — 9.5 Centimeter FDA UDI
Height — 6.9 Centimeter FDA UDI

Category: Cardiovascular patch, animal-derived

Biotronik BioEnvelope 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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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 13aff85c-ddbb-4f83-8bdc-e1950a32459f 36 fields · synced May 30, 2026