Catalog Number

-

Brand Name

HELIOS Ⅱ body

Version/Model Number

HELIOS Ⅱ 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

K083203,K083203

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

f291ed5a-1730-457e-98b0-f33f89b8bf38

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 10, 2018

Package DI Number

08800035500221

Quantity per Package

1

Contains DI Package

08800035500122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box