Catalog Number

X9007741

Brand Name

Senhance

Version/Model Number

X9007741

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

FWG

Product Code Name

Camera, Television, Endoscopic, With Audio

Public Device Record Key

12477923-d4be-4a49-b201-3fd08c8148eb

Public Version Date

July 11, 2022

Public Version Number

2

DI Record Publish Date

February 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-