Venaflo® ePTFE Vascular Grafts - Venaflo® ePTFE Vascular Graft WITH CARBON STEPPED - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: Venaflo® ePTFE Vascular Graft WITH CARBON STEPPED 4-6mm x 25cm

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More Product Details

Catalog Number

VT2546C

Brand Name

Venaflo® ePTFE Vascular Grafts

Version/Model Number

VT2546C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

eddd2c41-fed3-47ca-a7c3-1c680197097c

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 08, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARD PERIPHERAL VASCULAR, INC." Characteristics
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