Duns Number:610322518
Device Description: Fabric Bandages, 3/4 in x 3 in (1.9 cm x 7.6 cm)
Catalog Number
-
Brand Name
Assured
Version/Model Number
217338
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
f5ce0164-a579-4965-936a-fb8fd0ed52b9
Public Version Date
August 20, 2021
Public Version Number
4
DI Record Publish Date
May 29, 2020
Package DI Number
20639277079637
Quantity per Package
24
Contains DI Package
00639277079633
Package Discontinue Date
April 09, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |