Catalog Number

-

Brand Name

PICOPLUS

Version/Model Number

PICOPLUS 220V

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)

Yes

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

937c031a-5f83-4161-adbf-5240c30c863c

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2018

Package DI Number

08809447652023

Quantity per Package

1

Contains DI Package

08809447652016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden Box