Catalog Number

8000-010-003

Brand Name

TGS Navigation

Version/Model Number

8000-010-003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

6a3e2f5d-5f18-436e-b146-ace0703c5187

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

August 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-