Catalog Number

-

Brand Name

Bio-Eye®

Version/Model Number

I00022S

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

K982562

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Public Device Record Key

8a0b1805-e77d-4e15-9fd7-dec4791b6e12

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-