Catalog Number

-

Brand Name

TUNNELERTUNNELER

Version/Model Number

RTT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2019

Issuing Agency

In GS1

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

MZY

Product Code Name

Graft,vascular,stainless steel tunneler

Public Device Record Key

d8a3b0f2-35a2-48ce-90b5-b58b545efeec

Public Version Date

December 04, 2019

Public Version Number

3

DI Record Publish Date

July 28, 2017

Package DI Number

50884908039912

Quantity per Package

5

Contains DI Package

00884908039917

Package Discontinue Date

October 16, 2019

Package Status

Not in Commercial Distribution

Package Type

box