Catalog Number

-

Brand Name

TUNNELER

Version/Model Number

BTT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2021

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

fcb0c640-098e-4f2d-8086-ff29bc0aa885

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

50884908005375

Quantity per Package

5

Contains DI Package

00884908005370

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box