Duns Number:006999528
Device Description: Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm). Contains: Polyhe Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm). Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Catalog Number
-
Brand Name
Kroger
Version/Model Number
041260377501
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
f5c32d77-da13-4970-9f01-5cd821b0d5e0
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
Package DI Number
10041260377508
Quantity per Package
72
Contains DI Package
00041260377501
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |