Duns Number:052758618
Device Description: Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management o Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Catalog Number
08596
Brand Name
Resta Silver Gel Bellows Bottle
Version/Model Number
08596
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
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
772e762e-1921-4e32-b601-ab79ef0b70bf
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 07, 2021
Package DI Number
10190769085961
Quantity per Package
12
Contains DI Package
00190769085964
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |