Atraumatic Soft Tip - 23ga Atraumatic Soft Tip - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: 23ga Atraumatic Soft Tip

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More Product Details

Catalog Number

VS0210.23

Brand Name

Atraumatic Soft Tip

Version/Model Number

23ga

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

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

f50e4519-042e-41d8-8f19-6822186617a3

Public Version Date

September 24, 2018

Public Version Number

2

DI Record Publish Date

March 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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