25ga Internal Delivery Device (IDD) - 25ga Internal Delivery Device for use in - VORTEX SURGICAL, LLC

Duns Number:080375891

Device Description: 25ga Internal Delivery Device for use in viscodissection

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More Product Details

Catalog Number

VS0250.25

Brand Name

25ga Internal Delivery Device (IDD)

Version/Model Number

VS0250.25

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

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

aa545b31-368b-49ac-a463-27b052860c3f

Public Version Date

January 31, 2020

Public Version Number

1

DI Record Publish Date

January 23, 2020

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