Duns Number:610322518
Device Description: Sheer Bandages, assorted sizes, 3/4 in 3 in (1.9 cm x 7.6 cm); 3/4 in x 1 1/2 in (1.9 cm x Sheer Bandages, assorted sizes, 3/4 in 3 in (1.9 cm x 7.6 cm); 3/4 in x 1 1/2 in (1.9 cm x 3.8 cm); 1/3 in x 1 1/2 in (0.8 cm x 3.8 cm)
Catalog Number
-
Brand Name
Assured
Version/Model Number
234391
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 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
1122c6ea-dfa4-436f-8b23-cf3350943de5
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 29, 2020
Package DI Number
20639277232544
Quantity per Package
24
Contains DI Package
00639277232540
Package Discontinue Date
August 31, 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 |