Catalog Number

0620-0274

Brand Name

BladderScan®

Version/Model Number

Training Phantom

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2017

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

K022153,K071217,K153101,K915436,K022153,K071217,K153101,K915436

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

eae2d70a-545c-439f-9f5d-84245b709b11

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10879123002522

Quantity per Package

1

Contains DI Package

00879123002525

Package Discontinue Date

October 05, 2017

Package Status

Not in Commercial Distribution

Package Type

-