Duns Number:532201977
Device Description: Skin graft Carrier 60 cm
Catalog Number
9910102-60
Brand Name
4Med
Version/Model Number
9910102-60
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
c752a3b2-3b51-4251-a2d1-4214486cc5df
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 27, 2020
Package DI Number
07290018281116
Quantity per Package
20
Contains DI Package
07290018281109
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 |