Duns Number:007941230
Device Description: Marker Skin Correct Site With Sleeve Mini Gentian Violet Non-Sterile Single-Patient Use No Marker Skin Correct Site With Sleeve Mini Gentian Violet Non-Sterile Single-Patient Use Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MKR2250
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)
-
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
09ac8016-f3ab-4cc4-9ec3-5dc1909a1fed
Public Version Date
October 14, 2020
Public Version Number
1
DI Record Publish Date
October 06, 2020
Package DI Number
50885632120174
Quantity per Package
5
Contains DI Package
30885632120170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |