Catalog Number

300-11010

Brand Name

Senhance Ultrasonic

Version/Model Number

X9007619

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

Yes

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

K182421,K182421

Product Code

NAY

Product Code Name

System, Surgical, Computer Controlled Instrument

Public Device Record Key

d13a3cc4-a254-4442-bbfc-426f190cecd5

Public Version Date

July 11, 2022

Public Version Number

3

DI Record Publish Date

February 04, 2019

Package DI Number

10815440021563

Quantity per Package

10

Contains DI Package

00815440021566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case