Duns Number:006959555
Device Description: All-In-One Adhesive Pad, all one size, Dressing 3 1/2 IN x 4 1/2 IN (88 mm x 114 mm), Pad All-In-One Adhesive Pad, all one size, Dressing 3 1/2 IN x 4 1/2 IN (88 mm x 114 mm), Pad size 2 IN x 3 IN (50 mm x 76 mm)
Catalog Number
4212613
Brand Name
meijer
Version/Model Number
713733521659
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
c27a125c-9dc8-4ec4-8892-0df4855c1db9
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
Package DI Number
10713733521656
Quantity per Package
72
Contains DI Package
00713733521659
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |