Catalog Number

098502

Brand Name

NA

Version/Model Number

HMA-550F

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

22d3acdc-afd9-4df1-8ba0-4a1d095cd24e

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

01816901021872

Quantity per Package

5

Contains DI Package

00816901021873

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-