SealPTFE™ - SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis - VASCUTEK LTD

Duns Number:229053087

Device Description: SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY RE SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORCED WITH A PTFE SUPPORT

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More Product Details

Catalog Number

T5010PS

Brand Name

SealPTFE™

Version/Model Number

T5010PS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2019

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Record Status

Public Device Record Key

75c4dd72-0c1e-463c-bf1b-e1350838f99d

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

October 19, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VASCUTEK LTD" Characteristics
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