Catalog Number

M00658001R0

Brand Name

Genesys HTA System

Version/Model Number

M00658001R0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 19, 2021

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

-

Product Code

MNB

Product Code Name

DEVICE, THERMAL ABLATION, ENDOMETRIAL

Public Device Record Key

e5b31252-10c3-4341-9265-25ba3b36654c

Public Version Date

May 20, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-