Catalog Number

-

Brand Name

Bio-Eye®

Version/Model Number

I0018C

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

Yes

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

K003338

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Public Device Record Key

6702f04b-d467-4ac9-9fbf-bcf98b4ec231

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

December 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-