Duns Number:961027315
Device Description: Surgical Marking Pen Mini Regular Tip
Catalog Number
250SM
Brand Name
CARDINAL HEALTH
Version/Model Number
250SM
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
FZZ
Product Code Name
MARKER, SKIN
Public Device Record Key
a965e902-a103-473b-9abe-8ef3f8b46165
Public Version Date
January 21, 2020
Public Version Number
1
DI Record Publish Date
January 13, 2020
Package DI Number
50885380170049
Quantity per Package
12
Contains DI Package
20885380170048
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 | 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 |