Duns Number:091449079
Device Description: Hydrocolloid Island Dressing 4" x 12"
Catalog Number
-
Brand Name
Silverlon Antimicrobial Wound Dressing
Version/Model Number
IDHC-412
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
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
ae8511dd-3631-43fa-8955-2ae739320a38
Public Version Date
July 28, 2022
Public Version Number
2
DI Record Publish Date
July 01, 2021
Package DI Number
00840247300026
Quantity per Package
5
Contains DI Package
00857278000894
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |
U | Unclassified | 100 |