Catalog Number

-

Brand Name

Pioneer Elite Ergonomic Handpiece Sleeve

Version/Model Number

04073

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

63053f7b-ff23-4392-99dd-3f8f8089ab33

Public Version Date

December 04, 2019

Public Version Number

6

DI Record Publish Date

August 17, 2017

Package DI Number

00872320001605

Quantity per Package

1

Contains DI Package

00872320000868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack