Duns Number:079190073
Device Description: QuikClot Radial
Catalog Number
0374
Brand Name
QuikClot
Version/Model Number
0374
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
54a34dae-dba9-4950-8992-81026f6d8e14
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
September 27, 2017
Package DI Number
30841495103743
Quantity per Package
10
Contains DI Package
00841495103742
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 27 |