27ga Soft Tip Cannula - 27ga Soft Tip Cannula - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: 27ga Soft Tip Cannula

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More Product Details

Catalog Number

VS0200.27

Brand Name

27ga Soft Tip Cannula

Version/Model Number

VS0200.27

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

f3ded9ee-ae3d-412c-bc6f-85055ddccbf1

Public Version Date

September 04, 2019

Public Version Number

1

DI Record Publish Date

August 27, 2019

Additional Identifiers

Package DI Number

B384VS0200275

Quantity per Package

5

Contains DI Package

B384VS02002719

Package Discontinue Date

-

Package Status

In Commercial Distribution

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