Catalog Number

-

Brand Name

TRACOE® twist

Version/Model Number

REF 501-09

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K961449

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

3c889e96-c291-4f07-a117-bc384266e77f

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

October 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-