Duns Number:002347102
Device Description: Band-Aid Brand of First Aid Products Tru-Absorb Gauze Sponges, 4 Inches by 4 Inches, 2x50 Band-Aid Brand of First Aid Products Tru-Absorb Gauze Sponges, 4 Inches by 4 Inches, 2x50 Count
Catalog Number
-
Brand Name
BAND-AID Brand Adhesive Bandages
Version/Model Number
00381372020835
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
0858dacd-b7d4-4332-8456-3e7aa9abbdf9
Public Version Date
September 14, 2021
Public Version Number
1
DI Record Publish Date
September 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 307 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |