Catalog Number

9095

Brand Name

Checkpoint Guardian

Version/Model Number

9095

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

K092292,K092292,K092292,K092292

Product Code

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

f350ae6e-88b7-4d6f-a648-a53332cfda98

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

B13090951

Quantity per Package

1

Contains DI Package

B13090950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pouch