Duns Number:135057938
Device Description: IMPRA® ePTFE Vascular Graft, Carboflo® Straight Carbon-Lined, 4mm x 40cm
Catalog Number
40S04C
Brand Name
IMPRA® ePTFE Vascular Grafts
Version/Model Number
40S04C
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
-
Product Code
DSY
Product Code Name
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Public Device Record Key
2a002c4d-81ec-4b25-8f7c-69dc3bfa7288
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
April 17, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |