Catalog Number

-

Brand Name

N/A

Version/Model Number

5156

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2017

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"

-

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

KLX

Product Code Name

Electroglottograph

Public Device Record Key

3be269be-b1b6-4b45-888b-54b68d2134ac

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-