Duns Number:541290694
Device Description: The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is pr The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
Catalog Number
-
Brand Name
QuiCover
Version/Model Number
P0910122
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
K211570,K211570,K211570,K211570
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
0d6b7e68-be45-43dc-8e9b-ce0bfc6f3caf
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
Package DI Number
06972060310235
Quantity per Package
10
Contains DI Package
06972060310174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box