Catalog Number

LMI-700-EU

Brand Name

Leo Minor

Version/Model Number

LMI-700-EU

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

K142984

Product Code

FSY

Product Code Name

Light, surgical, ceiling mounted

Public Device Record Key

e5161270-b1da-4a86-971f-c917f1e6b0aa

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

March 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-