Catalog Number

AAIP16011201

Brand Name

Handpiece Cooled Dye VL (3) For HXL

Version/Model Number

1

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

K072564,K181298

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

61d1f22e-4987-44bb-ac2a-de47d83ca44d

Public Version Date

September 17, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-