Catalog Number

-

Brand Name

IMAGINA

Version/Model Number

EC34-i10cL

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

K190805,K190805

Product Code

FDF

Product Code Name

Colonoscope and accessories, flexible/rigid

Public Device Record Key

bbc14f8c-1c80-4fa9-852a-9a09b1ec6548

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-