VersaVit - VersaVIT™ Vitrectomy System - SYNERGETICS USA, INC.

Duns Number:021056726

Device Description: VersaVIT™ Vitrectomy System

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More Product Details

Catalog Number

VERSAVIT

Brand Name

VersaVit

Version/Model Number

VERSAVIT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HQE

Product Code Name

INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Device Record Status

Public Device Record Key

20e87d2f-0a88-44df-a477-c43c3afb0421

Public Version Date

October 29, 2018

Public Version Number

4

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERGETICS USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 336
2 A medical device with a moderate to high risk that requires special controls. 47