Duns Number:835465063
Device Description: CONSOLE NIM4CM01 NIM 4.0
Catalog Number
-
Brand Name
NIM Vital™
Version/Model Number
NIM4CM01
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
K200759
Product Code
ETN
Product Code Name
STIMULATOR, NERVE
Public Device Record Key
8cb7bcf5-8bdc-4133-a2d9-2c09fdeea3bb
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
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 | 665 |
2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
3 | A medical device with high risk that requires premarket approval | 6 |
U | Unclassified | 10 |