Catalog Number

SU0550EL

Brand Name

EndoBeam™ Holmium Laser Fiber

Version/Model Number

SU0550EL

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

-

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

c4b53fe7-6db2-4386-a44a-180f1be6fea6

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

August 22, 2016

Package DI Number

10801741122672

Quantity per Package

3

Contains DI Package

00801741122675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA