Duns Number:006261481
Device Description: ACTIVATOR 2696 PAT ASSIST 5L USM-R
Catalog Number
-
Brand Name
InCheck™ Patient Assistant
Version/Model Number
2696
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
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
P980035
Product Code
NVZ
Product Code Name
Pulse generator, permanent, implantable
Public Device Record Key
cb33df37-51d9-4e73-9fcc-2899db3b563f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |