Duns Number:835465063
Device Description: EMG TUBE 8229736 3PK NIM TRIVANTAGE 6MM
Catalog Number
-
Brand Name
NIM TriVantage®
Version/Model Number
8229736
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
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
K112686,K112686
Product Code
ETN
Product Code Name
STIMULATOR, NERVE
Public Device Record Key
7bba37a1-e2e4-48fc-aae0-bfc443609f57
Public Version Date
March 08, 2021
Public Version Number
3
DI Record Publish Date
February 29, 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 |