Duns Number:926603486
Device Description: bandage consisting of a medical dressing of plain absorbent gauze held in place by a plast bandage consisting of a medical dressing of plain absorbent gauze held in place by a plastic or fabric tape coated with adhesive
Catalog Number
DU3550
Brand Name
Cohesive bandage 2"x5yds stretched
Version/Model Number
1
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
3e566326-5962-445d-9ef0-e24037584aa8
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
August 06, 2020
Package DI Number
10850014433502
Quantity per Package
12
Contains DI Package
00850014433505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |