HITACHI - Needle Guide Bracket - HITACHI, LTD.

Duns Number:693002605

Device Description: Needle Guide Bracket

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More Product Details

Catalog Number

-

Brand Name

HITACHI

Version/Model Number

EZU-PA5C1

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

OIJ

Product Code Name

Biopsy Needle Guide Kit

Device Record Status

Public Device Record Key

fafc6e95-6146-4456-b4a0-630ffef26ed7

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2018

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