Duns Number:532201977
Device Description: Skin Graft Carrier 35 cm
Catalog Number
-
Brand Name
4Med
Version/Model Number
9910102-35
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
GEJ
Product Code Name
Carrier, Ligature
Public Device Record Key
6db4a456-ce01-4353-b1e6-298ed0e47109
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 27, 2020
Package DI Number
07290018281130
Quantity per Package
20
Contains DI Package
07290018281123
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 | 6 |