Catalog Number

-

Brand Name

FIBER COLONOSCOPE

Version/Model Number

FC-38FV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2017

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

-

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

a9563a10-cb99-43f8-b6e3-53a09ce02750

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-