23ga Bending Laser Probe - Iridex Compatible - 23ga Bending Laser Probe - Iridex Compatible - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: 23ga Bending Laser Probe - Iridex Compatible

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More Product Details

Catalog Number

VS0140.23I

Brand Name

23ga Bending Laser Probe - Iridex Compatible

Version/Model Number

VS0140.23I

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

K142830,K142830

Product Code Details

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Device Record Status

Public Device Record Key

44f19584-23a1-4bea-9295-fbbb3aa361ea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

B384VS014023I5

Quantity per Package

10

Contains DI Package

B384VS014023I1

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