Catalog Number

-

Brand Name

PicoLO Body

Version/Model Number

PicoLO Body

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

K203491,K203491,K203491

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b7297831-2582-4b2f-be6a-eb3b12a89a15

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

April 23, 2021

Package DI Number

08800035501259

Quantity per Package

1

Contains DI Package

08800035501174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carbon Box