Duns Number:008124539
Device Description: SiliGentle AG Silver Silicone Foam Dressing, Bordered, 4" x 4" (10cm x 10cm), High Absorbe SiliGentle AG Silver Silicone Foam Dressing, Bordered, 4" x 4" (10cm x 10cm), High Absorbency, For Wound Stages 2,3,4
Catalog Number
-
Brand Name
SiliGentle AG Silver Silicone Foam Dressing
Version/Model Number
3085
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
4fbe6452-6bb0-4b0e-b128-c181055276af
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 24, 2022
Package DI Number
00616784308524
Quantity per Package
10
Contains DI Package
00616784308517
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |