Catalog Number

-

Brand Name

EXALT™

Version/Model Number

M0054243R0

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

-

Product Code

FET

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

ae12affc-bd83-429b-b400-c5eac7c9d8dc

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

December 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-