Leaflet Tester - Livanova Canada Corp

Duns Number:243661431

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More Product Details

Catalog Number

-

Brand Name

Leaflet Tester

Version/Model Number

VT-100

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

LXN

Product Code Name

PROBE, TEST, HEART-VALVE

Device Record Status

Public Device Record Key

93e0deb4-01ac-4e5f-9d75-5979cc14cdca

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIVANOVA CANADA CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
3 A medical device with high risk that requires premarket approval 36