Duns Number:801380697
Device Description: ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
Catalog Number
-
Brand Name
ExcelArrest XT 2x2 Hemostatic Patch
Version/Model Number
9210223
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
K072900,K072900
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
dc3fb285-b803-4b66-9384-258b67726160
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
November 20, 2020
Package DI Number
00858439001705
Quantity per Package
10
Contains DI Package
00858439001699
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| U | Unclassified | 7 |