Catalog Number

L-MLED90-FS-XX-EX

Brand Name

MIRA Minor Surgery Light

Version/Model Number

MIRA

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

K131893

Product Code

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Public Device Record Key

9879feae-4dcc-4fb8-85c3-e33e6fe73769

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-