Catalog Number

-

Brand Name

Slimline EZ 550 Fiber

Version/Model Number

Slimline EZ 550 Fiber

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

K140388,K140388

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

fdf30ab3-a0c6-4166-92cd-9bd24a3159ee

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

17290109140183

Quantity per Package

3

Contains DI Package

07290109140186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-