Catalog Number

2233-002

Brand Name

ChannelScope

Version/Model Number

2233-002

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

K945633

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

e752f34f-f7b4-41f9-b72c-5aa6d61b8039

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-