Catalog Number

REF 373-4.0-C55

Brand Name

TRACOE silcosoft

Version/Model Number

REF 373-4.0-C55

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K172720

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Public Device Record Key

9080be91-7fad-4f3e-8070-1c48a2b59554

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

May 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-