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

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

EKX

Product Code Name

HANDPIECE, DIRECT DRIVE, AC-POWERED

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

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-