Duns Number:170199058
Device Description: Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contains: Polyhex Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Catalog Number
-
Brand Name
CareOne
Version/Model Number
041520078117
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
31378ce0-bccf-4b6f-846f-7ba88cdb1558
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
10041520078114
Quantity per Package
72
Contains DI Package
00041520078117
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 2 |