Duns Number:068331990
Device Description: Antibacterial, Pure-Tone, Fabric Bandages, All one size,3/4 in x 3 in (19 mm x 76 mm)
Catalog Number
-
Brand Name
Rexall
Version/Model Number
017276237306
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 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
138e3acf-4fcc-4533-b1aa-36d180abc51e
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
October 26, 2020
Package DI Number
20017276237300
Quantity per Package
72
Contains DI Package
00017276237306
Package Discontinue Date
April 29, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |