Catalog Number

-

Brand Name

VISCO(TM)360 Viscosurgical System

Version/Model Number

FG 03916

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

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

MRH

Product Code Name

Pump, Infusion, Ophthalmic

Public Device Record Key

a4b04173-8333-47f4-a45a-9b6a69309cc4

Public Version Date

October 27, 2020

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-