Catalog Number

O2IS

Brand Name

OSCAR 3

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

K093805

Product Code

JDX

Product Code Name

Instrument, Surgical, Sonic And Accessory/Attachment

Public Device Record Key

8abe484c-dc76-4ef8-9839-235ba41a1e21

Public Version Date

July 24, 2018

Public Version Number

5

DI Record Publish Date

September 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-