Catalog Number

000000-1005-825

Brand Name

i.Profiler plus

Version/Model Number

000000-1005-825

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

-

Product Code

HKO

Product Code Name

Refractometer, ophthalmic

Public Device Record Key

5a78a953-d7a0-466a-b65d-4b418335a2dc

Public Version Date

October 05, 2021

Public Version Number

2

DI Record Publish Date

January 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-