Catalog Number

-

Brand Name

ClearPath

Version/Model Number

AK-19-110

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

K210251,K210251,K210251

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

c1d400c9-de88-4fc5-9f04-7e01ba7afae8

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

Package DI Number

00860000321341

Quantity per Package

5

Contains DI Package

00860000321334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box