Catalog Number

-

Brand Name

Checkpoint Head & Neck

Version/Model Number

9394

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K150005,K150005,K150005

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

cc361bda-6602-4973-a07e-6b21dd9425c1

Public Version Date

July 02, 2021

Public Version Number

5

DI Record Publish Date

April 18, 2017

Package DI Number

B13093942

Quantity per Package

1

Contains DI Package

B13093941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-