Catalog Number

-

Brand Name

Infrared imaging unit

Version/Model Number

MAJ-2304

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2022

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

Yes

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

-

FDA Premarket Submission

K190772

Product Code

EPT

Product Code Name

MICROSCOPE, SURGICAL

Public Device Record Key

d7c752ff-28fd-4f92-bb22-24e74e7db4c9

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

May 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-