Catalog Number

OPO39

Brand Name

AMO VITREPURE VITRECTOMY HANDPIECES AND

Version/Model Number

OPO39

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

-

Product Code

HQE

Product Code Name

INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Public Device Record Key

fd31bcd7-a38f-4e83-9f14-d48f624b6d7b

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

15050474500201

Quantity per Package

6

Contains DI Package

05050474500204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box