Catalog Number

-

Brand Name

CyberWand Probe Set

Version/Model Number

CW-RBP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120303,K120303

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

d85982b3-d91c-4f50-8b93-7d05785f7573

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 23, 2016

Package DI Number

H891CWRBPBX3

Quantity per Package

3

Contains DI Package

H891CWRBP1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-