LF - Illumena Néo Contrast Delivery System (formerly - Liebel-Flarsheim Company LLC

Duns Number:080186051

Device Description: Illumena Néo Contrast Delivery System (formerly known as Angiomat Illumena)

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More Product Details

Catalog Number

-

Brand Name

LF

Version/Model Number

900001

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

-

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

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

e62d4d87-687a-4ee7-b4e9-4cf3035edf9f

Public Version Date

January 05, 2022

Public Version Number

5

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIEBEL-FLARSHEIM COMPANY LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 75