Duns Number:062312574
Device Description: Antibacterial, Rapid Seal Wound Gel, 14 uses, 0.5 FL OZ (14 mL)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
564570
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)
-
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
9244d386-ec9d-439d-9ef6-23e1985fa2d0
Public Version Date
April 16, 2021
Public Version Number
1
DI Record Publish Date
April 08, 2021
Package DI Number
20050428490734
Quantity per Package
36
Contains DI Package
00050428490730
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |