Catalog Number

-

Brand Name

EASYRET

Version/Model Number

EASYRET

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

K170067

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

529a7634-1a4c-406f-a70f-6f1e581ccb2f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-