Duns Number:080935429
Device Description: Skin Marker,Dual Tip with Ruler Cap and Flexible Ruler
Catalog Number
31160560
Brand Name
Devon
Version/Model Number
31160560
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)
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
4b5a470e-5c93-466e-8bfc-2ccf94807a7f
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 29, 2018
Package DI Number
10884527007554
Quantity per Package
25
Contains DI Package
30884527007558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |