Catalog Number

579039

Brand Name

Odyssey

Version/Model Number

579039

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2021

Issuing Agency

In HIBCC

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

-

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

f32d7768-79ca-4558-8400-7f334da68c70

Public Version Date

March 04, 2021

Public Version Number

3

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-