Duns Number:023904428
Device Description: Surgical Skin Marker Regular tip Sterile
Catalog Number
-
Brand Name
McKesson
Version/Model Number
19-0752
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)
Yes
Over the Counter (OTC)
-
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
67bdadc8-daa0-4ee4-9c61-04aa38d5870e
Public Version Date
April 17, 2020
Public Version Number
1
DI Record Publish Date
April 09, 2020
Package DI Number
40612479160857
Quantity per Package
50
Contains DI Package
20612479160846
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |