Duns Number:961027315
Device Description: Cannulated Countersink 3.5mm/4.0mm Cannulated Screws
Catalog Number
CH04-0001
Brand Name
CARDINAL HEALTH
Version/Model Number
CH04-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 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
-
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
HWW
Product Code Name
COUNTERSINK
Public Device Record Key
e8419363-ae92-42fb-a7ac-1eed5aeace03
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
June 05, 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 |