Duns Number:080251450
Device Description: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to cr 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.
Catalog Number
-
Brand Name
Biotronik BioEnvelope
Version/Model Number
440575
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTM
Product Code Name
Mesh, Surgical
Public Device Record Key
4b6776b9-6420-4831-a1a6-0d66e2a13bb7
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
August 26, 2019
Package DI Number
04035479160630
Quantity per Package
5
Contains DI Package
04035479160517
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |