Catalog Number

OPOCR4520R

Brand Name

LAMINAR

Version/Model Number

OPOCR4520R

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

-

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

HQC

Product Code Name

Unit, phacofragmentation

Public Device Record Key

fdd4dedf-cce6-455a-b7a8-0402952b0548

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

15050474537146

Quantity per Package

6

Contains DI Package

05050474537149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box