Catalog Number

500-21017

Brand Name

Senhance

Version/Model Number

X9007649

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

K171120

Product Code

NAY

Product Code Name

System, Surgical, Computer Controlled Instrument

Public Device Record Key

9b9cb1de-0c04-4311-aa68-ef2a50a267f4

Public Version Date

July 11, 2022

Public Version Number

2

DI Record Publish Date

February 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-