Duns Number:014578892
Device Description: Advanced, 100% Waterproof, Fast-Healing+ adhesive Clear Bandages, all one size, 3/4 IN x 3 Advanced, 100% Waterproof, Fast-Healing+ adhesive Clear Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
0371936
Brand Name
Rite Aid Pharmacy
Version/Model Number
011822037815
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
698661af-467c-48f7-be47-5221718280d1
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
May 11, 2021
Package DI Number
10011822037812
Quantity per Package
72
Contains DI Package
00011822037815
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |