Catalog Number

-

Brand Name

Inverter Vitrectomy System Set For Leica Type Microscopes

Version/Model Number

OIVS2L-WE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HRM

Product Code Name

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

Public Device Record Key

90e34506-e5db-4bd7-9848-8c519be614ae

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-