Catalog Number

EMERALDT

Brand Name

UNFOLDER EMERALD

Version/Model Number

EMERALDT

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

K961242

Product Code

KYB

Product Code Name

LENS, GUIDE, INTRAOCULAR

Public Device Record Key

e848a1d3-9502-47bd-98a3-e8342e78e9c9

Public Version Date

February 26, 2020

Public Version Number

2

DI Record Publish Date

February 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-