Catalog Number

-

Brand Name

Harmony

Version/Model Number

5.05.101

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

K182376

Product Code

NFJ

Product Code Name

System, Image Management, Ophthalmic

Public Device Record Key

a3fbcbd7-0fae-4973-bd9a-df58adc04657

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-