Duns Number:211352227
Device Description: Antimicrobial Binding Dressing
Catalog Number
190220
Brand Name
ACTISORB® SILVER 220
Version/Model Number
190220
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)
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
86af7072-42d6-41a4-847a-00655ba14776
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2019
Package DI Number
25051978002724
Quantity per Package
10
Contains DI Package
15051978002727
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 | 66 |
U | Unclassified | 12 |