Catalog Number

500395

Brand Name

HUMANSCAN

Version/Model Number

5833059

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

7160ba9e-7310-4605-a12f-951f57bd770e

Public Version Date

May 19, 2021

Public Version Number

2

DI Record Publish Date

July 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-