25ga Edge Advantage ILM Elevator - 25ga ILM Elevator - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: 25ga ILM Elevator

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More Product Details

Catalog Number

VS0300.25

Brand Name

25ga Edge Advantage ILM Elevator

Version/Model Number

VS0300.25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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 Details

Product Code

HNQ

Product Code Name

Hook, Ophthalmic

Device Record Status

Public Device Record Key

647c7c42-d2e3-4e93-9b5e-243f56af1cb0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2016

Additional Identifiers

Package DI Number

B384VS0300255

Quantity per Package

5

Contains DI Package

B384VS0300251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VORTEX SURGICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 23