Duns Number:047741335
Device Description: Advance Fast Healing Clear Adhesive Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
-
Brand Name
Discount Drug Mart Food Fair
Version/Model Number
093351027888
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2021
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
0aed64d6-28fb-4221-931d-d34349273735
Public Version Date
August 17, 2021
Public Version Number
3
DI Record Publish Date
August 24, 2020
Package DI Number
20093351027882
Quantity per Package
72
Contains DI Package
00093351027888
Package Discontinue Date
June 03, 2021
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |