| Primary Device ID | 04035479160548 |
| NIH Device Record Key | 13aff85c-ddbb-4f83-8bdc-e1950a32459f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotronik BioEnvelope |
| Version Model Number | 440578 |
| 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 |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| Width | 9.5 Centimeter |
| Height | 6.9 Centimeter |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479160548 [Primary] |
| GS1 | 04035479160654 [Package] Package: Box [5 Units] In Commercial Distribution |
| FTM | Mesh, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2019-08-26 |
| 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 |