Duns Number:942377524
Device Description: Integra® NuGrip®The CMC disposable pack for Stryker includes a blade, a 5mm spherical bur Integra® NuGrip®The CMC disposable pack for Stryker includes a blade, a 5mm spherical burr and an 8mm spherical burr.
Catalog Number
CMC-DIS-STR
Brand Name
NuGrip® CMC Implant System
Version/Model Number
CMC-DIS-STR
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
-
Product Code
HTT
Product Code Name
BURR, ORTHOPEDIC
Public Device Record Key
07ba6dc6-ca42-49b9-9810-621f41340a33
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 2017
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |