Catalog Number

TIVH30

Brand Name

Tru-Incise Valvulotome with Interchangeable Heads

Version/Model Number

TIVH30

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2020

Issuing Agency

In HIBCC

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

MGZ

Product Code Name

Valvulotome

Public Device Record Key

2878ab58-7fba-476a-9bb4-2edccf22be04

Public Version Date

December 15, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2019

Package DI Number

H862TIVH30NC2

Quantity per Package

10

Contains DI Package

H862TIVH30NC1

Package Discontinue Date

October 23, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipper