Catalog Number

-

Brand Name

TRACOE® larynx

Version/Model Number

REF 601-11

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

-

Product Code

KAC

Product Code Name

TUBE, LARYNGECTOMY

Public Device Record Key

7e90dc44-0ac7-4a16-920a-aa0ac5f508b8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-