Catalog Number

-

Brand Name

IwavePhoropter

Version/Model Number

IwavePhoropter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

HKN

Product Code Name

Refractor, Manual, Non-Powered, Including Phoropter

Public Device Record Key

78ffb60d-ff50-410a-b014-bbbb31983819

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

October 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-