Catalog Number

002-00252

Brand Name

Precise SHP Therapy Handpiece Sleeve

Version/Model Number

002-00252

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

K123443

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

de00a16d-da55-4b27-bf16-baf7a7932de2

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-