Catalog Number

-

Brand Name

StimGuide Trigger Lead

Version/Model Number

5293-00

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"

-

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

K183376

Product Code

OBP

Product Code Name

Transcranial Magnetic Stimulator

Public Device Record Key

9c7f5bfb-6351-4afd-b829-62745bd722e0

Public Version Date

September 06, 2019

Public Version Number

1

DI Record Publish Date

August 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-