Catalog Number

PR00104-01

Brand Name

Lens Exchange Sytem

Version/Model Number

G25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

KYB

Product Code Name

Lens, Guide, Intraocular

Public Device Record Key

1608c2e7-7bc0-4d60-bd37-549e301ef149

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-