SH42 - OSADA ELECTRIC CO.,LTD.

Duns Number:690713813

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More Product Details

Catalog Number

55741

Brand Name

SH42

Version/Model Number

SH42

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 07, 2017

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EKX

Product Code Name

HANDPIECE, DIRECT DRIVE, AC-POWERED

Device Record Status

Public Device Record Key

ce165480-c55d-4f8e-900a-4f80e470c157

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSADA ELECTRIC CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 108
U Unclassified 8