Catalog Number

-

Brand Name

HIT Laser

Version/Model Number

HIT Red

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

-

Product Code

IWE

Product Code Name

Monitor, Patient Position, Light-Beam

Public Device Record Key

9883e070-9174-4b5f-ab73-a02f013d404d

Public Version Date

July 24, 2020

Public Version Number

1

DI Record Publish Date

July 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-