27ga Illuminated Infusion Cannula - 27ga Illuminated Infusion Cannula - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: 27ga Illuminated Infusion Cannula

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More Product Details

Catalog Number

-

Brand Name

27ga Illuminated Infusion Cannula

Version/Model Number

V2201-27

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

MPA

Product Code Name

Endoilluminator

Device Record Status

Public Device Record Key

d8f86c93-a685-4a4c-a896-215c925ccd46

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288