Duns Number:216344051
Device Description: 7 day silver-coated antimicrobial barrier dressing
Catalog Number
20241
Brand Name
ACTICOAT 7 6" X 6"
Version/Model Number
20241
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K001519,K001519,K001519
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
c699d5ab-f1ff-42f2-9f39-8f598c4609c3
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
00040565121451
Quantity per Package
5
Contains DI Package
05000223449940
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |