Duns Number:014578892
Device Description: Advanced antibacterial, Sheer adhesive Bandages, assorted sizes, 14- 7/8 IN (22 mm); 34- Advanced antibacterial, Sheer adhesive Bandages, assorted sizes, 14- 7/8 IN (22 mm); 34- 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 30- 3/4 IN x 3 IN (19 mm x 76 mm); 2- 2 1/4 IN x 3 IN (57 mm x 76 mm)
Catalog Number
8019010
Brand Name
Rite Aid Pharmacy
Version/Model Number
011822411554
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
1afd59b3-dfed-4ebc-9716-ca37230724d4
Public Version Date
June 01, 2021
Public Version Number
1
DI Record Publish Date
May 24, 2021
Package DI Number
10011822411551
Quantity per Package
72
Contains DI Package
00011822411554
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 |