Duns Number:112164780
Device Description: English
Catalog Number
CAH4403
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH4403
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
e73858d7-155a-453f-9338-b1bf69b6e0be
Public Version Date
May 02, 2019
Public Version Number
1
DI Record Publish Date
April 24, 2019
Package DI Number
50885380170315
Quantity per Package
24
Contains DI Package
20885380170314
Package Discontinue Date
-
Package Status
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 | 81 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |