Duns Number:961027315
Device Description: Standard Prep Blade
Catalog Number
CAH4406D
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH4406D
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"
Yes
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
c11d8b80-2f62-40e1-994e-e52f80fc3590
Public Version Date
March 08, 2019
Public Version Number
1
DI Record Publish Date
February 05, 2019
Package DI Number
30192253002113
Quantity per Package
25
Contains DI Package
20192253002116
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |