Catalog Number

-

Brand Name

HandyRay

Version/Model Number

LMT-3000

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

K172818,K172818,K172818,K172818,K172818

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c8c1b81c-566e-43e9-9920-efec93008a3b

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Package DI Number

08800031600055

Quantity per Package

100

Contains DI Package

08800031600017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-