Duns Number:014578892
Device Description: Waterproof, Flexible Foam, Sterile Adhesive Pad, all one size, Dressing- 3.5 IN x 4.5 IN ( Waterproof, Flexible Foam, Sterile Adhesive Pad, all one size, Dressing- 3.5 IN x 4.5 IN (88 mm x 114 mm), Pad Size- 2 IN x 3 IN (50 mm x 76 mm)
Catalog Number
-
Brand Name
Rite Aid
Version/Model Number
011822089142
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
abb616c1-feee-40a6-95ee-3f7451ff3c46
Public Version Date
September 16, 2021
Public Version Number
2
DI Record Publish Date
March 09, 2021
Package DI Number
10011822089149
Quantity per Package
72
Contains DI Package
00011822089142
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 |