Duns Number:023055619
Device Description: SCANLAN® Surgical skin markers - Regular Tip, Gentian Violet (1 per sterile package with SCANLAN® Surgical skin markers - Regular Tip, Gentian Violet (1 per sterile package with ruler)
Catalog Number
1001-710
Brand Name
SCANLAN® Surgical skin markers
Version/Model Number
1001-710
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
FZZ
Product Code Name
Marker, Skin
Public Device Record Key
8a70ec9e-895e-4f14-b6b2-ed0912b1ef63
Public Version Date
September 10, 2019
Public Version Number
2
DI Record Publish Date
December 11, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |