Catalog Number

-

Brand Name

MI Product Line

Version/Model Number

061412-V

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140812,K140812

Product Code

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Public Device Record Key

426ee089-7ca5-4416-8961-11debe35b6e2

Public Version Date

September 19, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

01816835020613

Quantity per Package

1

Contains DI Package

00816835020614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX