LifeStent® Solo Vascular Stent - LIFESTENT® SOLO™ Vascular Stent System 7 mm x 170 - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: LIFESTENT® SOLO™ Vascular Stent System 7 mm x 170 mm (80 cm delivery catheter)

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More Product Details

Catalog Number

EX071701CL

Brand Name

LifeStent® Solo Vascular Stent

Version/Model Number

EX071701CL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

NIP

Product Code Name

STENT, SUPERFICIAL FEMORAL ARTERY

Device Record Status

Public Device Record Key

8d265feb-633f-4a60-9b32-67dcfadb879e

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

September 17, 2014

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