HITACHI - Probe - HITACHI, LTD.

Duns Number:693002605

Device Description: Probe

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More Product Details

Catalog Number

-

Brand Name

HITACHI

Version/Model Number

C22K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

dff04ce4-4364-4514-bb0c-dbeb9d841b44

Public Version Date

July 05, 2021

Public Version Number

4

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HITACHI, LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 308