Duns Number:229053087
Device Description: MAXIFLO ePTFE Vascular Prosthesis Standard Wall Wrap
Catalog Number
S8005
Brand Name
MAXIFLO™
Version/Model Number
S8005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 30, 2019
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
DYF
Product Code Name
PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
Public Device Record Key
1e8f4706-8674-48ef-a1ce-1eb4e3a87368
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1682 |
| 3 | A medical device with high risk that requires premarket approval | 40 |