Duns Number:961523441
Device Description: A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemo A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked with an X-shaped radiopaque marker.
Catalog Number
FIN-0001-04
Brand Name
XSTAT
Version/Model Number
XSTAT 12
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"
Yes
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
K161020,K161020
Product Code
PGZ
Product Code Name
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Public Device Record Key
64666c0f-ab1c-4ccd-b2e9-180b4043f734
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
September 02, 2016
Package DI Number
10851587006049
Quantity per Package
3
Contains DI Package
00851587006042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Flexible Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |