Catalog Number

EPY-50

Brand Name

EPY-50

Version/Model Number

EPY-50

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

K020513

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

25779a3c-d532-4302-af96-76bde5dd4b26

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-