Duns Number:080251450
Device Description: The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic devic 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 cordneuromodulators, deep brain stimulators and sacral nerve stimulators.
Catalog Number
-
Brand Name
CanGaroo Envelope
Version/Model Number
CMCV-009-MED
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
57d5b95b-c930-4af2-b513-7aada64c82b9
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
July 01, 2015
Package DI Number
10859389005031
Quantity per Package
5
Contains DI Package
00859389005034
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 |