Catalog Number

G80-01

Brand Name

Gentuity

Version/Model Number

Gentuity Review Station

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

K192922

Product Code

NQQ

Product Code Name

System, Imaging, Optical Coherence Tomography (Oct)

Public Device Record Key

d3abb36f-d6b0-48fb-9bf6-8fda5e164eac

Public Version Date

August 25, 2022

Public Version Number

1

DI Record Publish Date

August 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-