Duns Number:961027315
Device Description: Specialty Blade
Catalog Number
CAH4412D
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH4412D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LWK
Product Code Name
RAZOR, SURGICAL
Public Device Record Key
d0637cdb-3000-43a2-984e-3efaeaee7261
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
September 18, 2018
Package DI Number
50885380164826
Quantity per Package
4
Contains DI Package
10885380164828
Package Discontinue Date
February 18, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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 |