Duns Number:062312574
Device Description: Sterile Antibacterial Non-Stick Pads, 3 IN x 4 IN (7.6 cm x 10.1 cm). Contains: Polyhexame Sterile Antibacterial Non-Stick Pads, 3 IN x 4 IN (7.6 cm x 10.1 cm). Contains: Polyhexamethylene Biguanide (PHMB) 0.2%
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
984301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2020
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"
Yes
For Single-Use
Yes
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
bc9accff-51a4-4630-9b9c-2c9dcce0252e
Public Version Date
January 07, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
20050428327962
Quantity per Package
72
Contains DI Package
00050428327968
Package Discontinue Date
September 25, 2020
Package Status
Not 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 |