Catalog Number

-

Brand Name

DURATWIX

Version/Model Number

19801-09

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2021

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

e4367177-7097-40e2-80bd-e54f5bc28493

Public Version Date

October 13, 2021

Public Version Number

4

DI Record Publish Date

January 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-