Catalog Number

-

Brand Name

Luma Rx

Version/Model Number

SP6800SB

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140631,K140631

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

cb2e727b-20ad-44ba-b332-897c31701f15

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

10074590542377

Quantity per Package

60

Contains DI Package

00074590542370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box