OSADA XL-S40 - OSADA ELECTRIC CO.,LTD.

Duns Number:690713813

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

3285

Brand Name

OSADA XL-S40

Version/Model Number

XL-S40

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 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

3e3932ea-7320-45dd-af6d-3abdd14a2019

Public Version Date

March 29, 2018

Public Version Number

2

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