Duns Number:079190073
Device Description: QuikClot Hemostatic Dressing 2x2 ,CE,Multi-lang10x
Catalog Number
0302
Brand Name
QuikClot
Version/Model Number
0302
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
25a0d6b1-a742-4783-a737-033f6b950569
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
June 01, 2018
Package DI Number
50841495103020
Quantity per Package
24
Contains DI Package
30841495103026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 27 |