Catalog Number

-

Brand Name

HELIOS IV 785 Body

Version/Model Number

HELIOS IV 785 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

K212663,K212663,K212663

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

270891d4-4151-4693-b502-7afaea743811

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Package DI Number

08800035501549

Quantity per Package

1

Contains DI Package

08800035501426

Package Discontinue Date

June 17, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton box