Catalog Number

-

Brand Name

Hydroxyapatite Orbital Implant

Version/Model Number

SP16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2021

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

K110554

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Public Device Record Key

4454ef38-3090-40a8-a845-62b524cc6831

Public Version Date

October 21, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-