Catalog Number

-

Brand Name

ISOTECHNICS

Version/Model Number

UN50A-07.0

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"

-

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

P880072

Product Code

HQL

Product Code Name

Intraocular Lens

Public Device Record Key

2f1b41d9-fe30-4638-b90b-ddb4bd6cd7bf

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-