Duns Number:009260217
Device Description: 25% aluminum sulfate gel - 25 - 0.32g MicroPoint Cartridges.
Catalog Number
15505
Brand Name
Gel Cord Topical Hemostatic Gel MicroPoints
Version/Model Number
15505
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
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
cdeb4a51-b39f-4dfa-8887-945e239a9d0a
Public Version Date
March 01, 2019
Public Version Number
1
DI Record Publish Date
January 29, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 34 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |
U | Unclassified | 57 |