Duns Number:229053087
Device Description: SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin W SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORCED WITH A PTFE SUPPORT
Catalog Number
T8008PS
Brand Name
SealPTFE™
Version/Model Number
T8008PS
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
DSY
Product Code Name
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Public Device Record Key
c1112cb7-dbb3-4884-b1af-3d50b9df6d85
Public Version Date
February 05, 2021
Public Version Number
7
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 |