Catalog Number

-

Brand Name

invendoscope

Version/Model Number

SC210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2019

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

K173085,K173085

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

d236d47b-d79b-408f-98f6-932275e32b84

Public Version Date

June 19, 2019

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

04260444390129

Quantity per Package

5

Contains DI Package

04260444390112

Package Discontinue Date

June 18, 2019

Package Status

Not in Commercial Distribution

Package Type

-