Catalog Number

002-00203

Brand Name

Precise LTM Handpiece

Version/Model Number

002-00203

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062619,K062619,K062619

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

4cf1c7a6-dc9e-4c1a-8add-59d2b7a4e6e7

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

November 10, 2016

Package DI Number

00872320003159

Quantity per Package

1

Contains DI Package

00872320001391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

HP+Cleaver