Catalog Number

EMP-H100

Brand Name

Empower H100

Version/Model Number

PVMS00053

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2018

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

K180922

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

a1305747-2f5c-4244-bdc1-38c20e496bb6

Public Version Date

December 20, 2018

Public Version Number

3

DI Record Publish Date

May 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-