Catalog Number

1007-0-10

Brand Name

N/A

Version/Model Number

1007-0-10

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

-

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

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Public Device Record Key

69e61b3c-55e6-4394-988f-e131378156ec

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

November 30, 2016

Package DI Number

20607411001141

Quantity per Package

25

Contains DI Package

10607411001144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-