Biotronik BioEnvelope

GUDID 04035479160531

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.

AZIYO BIOLOGICS, INC.

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 04035479160531
• NIH Device Record Key: 432a1e97-9287-463a-a669-204c48ab066a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronik BioEnvelope
• Version Model Number: 440577
• Company DUNS: 080251450
• Company Name: AZIYO BIOLOGICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com
• Phone: 470-514-4080
• Email: customerservice@aziyo.com

Device Dimensions

• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter
• Width: 8 Centimeter
• Height: 6.9 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479160531 [Primary]
GS1	04035479160616 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• FTM: Mesh, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2019-08-26

On-Brand Devices [Biotronik BioEnvelope]

• 04035479160647: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a
• 04035479160548: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a
• 04035479160531: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a
• 04035479160524: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a
• 04035479160517: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a