Catalog Number

CS200

Brand Name

ClearScan®

Version/Model Number

CS200

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"

Yes

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

K080119,K080119

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

c325c211-b689-49ff-836a-d2d322259acd

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

B360CS2001

Quantity per Package

10

Contains DI Package

B360CS2000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX