Duns Number:961027315
Device Description: Cardinal Health Navigation Pins Stainless Steel
Catalog Number
CH003-150N
Brand Name
CARDINAL HEALTH
Version/Model Number
CH003-150N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 28, 2018
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
K131264,K131264
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
027016fd-0ae9-4055-888e-e50b0b9e9d54
Public Version Date
July 30, 2018
Public Version Number
2
DI Record Publish Date
June 28, 2018
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |