Duns Number:985523874
Device Description: Cohesiant Wrap 4 in X 5 yd (Assorted Pack Fluorescent) (Fluorescent Green, Fluorescent Pin Cohesiant Wrap 4 in X 5 yd (Assorted Pack Fluorescent) (Fluorescent Green, Fluorescent Pink, Fluorescent Orange)
Catalog Number
-
Brand Name
AmerisourceBergen
Version/Model Number
10249
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
29a19303-dc1c-4167-80c8-b67491f80965
Public Version Date
October 08, 2021
Public Version Number
1
DI Record Publish Date
September 30, 2021
Package DI Number
60368001102492
Quantity per Package
12
Contains DI Package
20368001102494
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |