Duns Number:152793493
Device Description: Antibacterial Gauze Pads, 4 IN x 4 IN (101mm x 101mm), 2 pads per wrapper
Catalog Number
-
Brand Name
CARE SCIENCE
Version/Model Number
017276238969
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
eee973df-d66e-4e1f-9f8e-1bba66ac513f
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
20017276238963
Quantity per Package
12
Contains DI Package
00017276238969
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |