Duns Number:315768788
Device Description: Sorbalgon Ag st 15x15cm P5
Catalog Number
-
Brand Name
Sorbalgon Ag st 15x15cm P5
Version/Model Number
999610
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ec5b67c5-e568-489b-b5e8-218bc290a27a
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 2020
Package DI Number
20612553018087
Quantity per Package
5
Contains DI Package
10612553018080
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 | 99 |
U | Unclassified | 1 |