Catalog Number

-

Brand Name

NiA

Version/Model Number

3805-012

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"

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

K990333,K990333

Product Code

GWG

Product Code Name

Endoscope, neurological

Public Device Record Key

981553a1-7128-4b45-82c0-d3cedb6c3cff

Public Version Date

February 09, 2021

Public Version Number

4

DI Record Publish Date

April 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-