Duns Number:006959555
Device Description: Smart-Flex, Sterile Adhesive Bandages, assorted sizes: 5/8 IN x 2 1/4 IN (15 mm x 57 mm); Smart-Flex, Sterile Adhesive Bandages, assorted sizes: 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 7/8 IN x 2 3/4 IN (22 mm x 69 mm); 1 1/8 IN x 2 5/8 IN (28 mm x 67 mm)
Catalog Number
4430873
Brand Name
meijer
Version/Model Number
708820390461
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 09, 2022
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
5a82c78c-a9ad-4cdd-913c-77cbd6db0481
Public Version Date
August 04, 2022
Public Version Number
4
DI Record Publish Date
July 31, 2019
Package DI Number
10708820390468
Quantity per Package
72
Contains DI Package
00708820390461
Package Discontinue Date
February 09, 2022
Package Status
Not 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |