Catalog Number

FS10003

Brand Name

F-HR*

Version/Model Number

FS10003

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

K153566,K160195

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

62f92ca0-e578-45ea-9452-f2f71abf43ed

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-