Duns Number:013469890
Device Description: Standard Pen Genian Violet, 20/bx. Our surgical marking pens contain a large reservoir if Standard Pen Genian Violet, 20/bx. Our surgical marking pens contain a large reservoir if medical grade non-irrating gentian violet ink.
Catalog Number
MK-9001
Brand Name
Pro-Paks
Version/Model Number
MK-9001
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"
-
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
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
e889e84c-486e-4925-b51a-75c724f75de5
Public Version Date
November 21, 2019
Public Version Number
1
DI Record Publish Date
November 13, 2019
Package DI Number
30810003223433
Quantity per Package
20
Contains DI Package
10810003223439
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |