Catalog Number

9SYS7852

Brand Name

Ellipse

Version/Model Number

Ydun

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

-

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

K180406,K180406

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

0bdd05a8-8ecd-4912-b397-038315588569

Public Version Date

May 24, 2021

Public Version Number

2

DI Record Publish Date

June 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-