Catalog Number

8000-100-001

Brand Name

n/a

Version/Model Number

8000-100-001

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

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

-

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

28643349-d0eb-4122-88d8-f0b357ad187a

Public Version Date

February 18, 2020

Public Version Number

2

DI Record Publish Date

August 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-