Duns Number:229053087
Device Description: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis
Catalog Number
T2010PS
Brand Name
SealPTFE™
Version/Model Number
T2010PS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 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
20d40728-f16b-47ca-a880-519942a7abbf
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
April 01, 2019
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 |