VSI Radiofrequency Ablation Procedure Pack with 7F 7cm Introducer Kit - Vascular Solutions, Inc.

Duns Number:008999906

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More Product Details

Catalog Number

-

Brand Name

VSI Radiofrequency Ablation Procedure Pack with 7F 7cm Introducer Kit

Version/Model Number

7788

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

LRO

Product Code Name

General Surgery Tray

Device Record Status

Public Device Record Key

f5be13fd-e576-4e37-b17b-b47ea5db46a9

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VASCULAR SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 238
U Unclassified 12