Duns Number:604056226
Device Description: Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler & 6 labels
Catalog Number
-
Brand Name
Key Surgical Skin Markers
Version/Model Number
SM-300
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)
-
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
d11f55e4-c124-4f8c-885f-f4c77e3687c1
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2020
Package DI Number
10849771030482
Quantity per Package
50
Contains DI Package
00849771030485
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |