Catalog Number

-

Brand Name

CERTAIN® IOL®

Version/Model Number

IIOL55S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2017

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

-

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Public Device Record Key

817737d3-2735-4861-bd44-3cc63a28008c

Public Version Date

March 10, 2022

Public Version Number

5

DI Record Publish Date

September 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-