Catalog Number

220-11029

Brand Name

Senhance

Version/Model Number

X0007513

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

NAY

Product Code Name

System, Surgical, Computer Controlled Instrument

Public Device Record Key

e2c37c77-5e2f-4b70-aa31-5e817dde79b8

Public Version Date

July 11, 2022

Public Version Number

2

DI Record Publish Date

November 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-