Catalog Number

-

Brand Name

Endoscopic Optical Coupler

Version/Model Number

5189-001

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

-

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

K003914

Product Code

GWG

Product Code Name

ENDOSCOPE, NEUROLOGICAL

Public Device Record Key

5416f60d-9d55-4e43-a3ba-e7e391b1374d

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

June 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-