Duns Number:022348156
Device Description: EXXCEL SOFT STD WALL STR EXT S 6/70/50
Catalog Number
M002004847560
Brand Name
Exxcel Soft ePTFE Vascular Graft
Version/Model Number
M002004847560
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"
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
K962433
Product Code
DSY
Product Code Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Public Device Record Key
13d20ba1-1b07-40b9-a2e1-d8c7f310909f
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 24, 2015
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 184 |