Catalog Number

-

Brand Name

HYPERION Service Manual

Version/Model Number

HYPERION Service Manual

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

K132286

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

bb878479-bf03-4191-ad22-e46d9bbfcc36

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

January 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-