Catalog Number

-

Brand Name

FemTouch™ Standard Focus Disposable Tips

Version/Model Number

FemTouch™ Standard Focus Disposable Tips Pack

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)

-

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

e8b41ffc-00fd-480e-b39c-e7a4c8ff4363

Public Version Date

January 20, 2022

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

17290109143078

Quantity per Package

10

Contains DI Package

07290109143071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-