Catalog Number

AS90245

Brand Name

Hand Piece, external hygienic, Packaged, CO2RE 

Version/Model Number

AS90245

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

Yes

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

K151655,K151655

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

bfdbf9d8-ac7a-459c-a717-87a7b303b422

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

March 09, 2017

Package DI Number

17290109952380

Quantity per Package

5

Contains DI Package

07290109952383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-