Duns Number:062312574
Device Description: Antibacterial Rolled Cotton Gauze, 4 IN x 4.1 YDS (11.4 cm x 3.7 m) stretched. Contains: P Antibacterial Rolled Cotton Gauze, 4 IN x 4.1 YDS (11.4 cm x 3.7 m) stretched. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
248565
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"
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
dd8df13e-3bc1-41e9-8cb5-a333acf0723e
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
December 09, 2019
Package DI Number
20050428356214
Quantity per Package
36
Contains DI Package
00050428356210
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 |