Ilivia Neo 7 VR-T - BIOTRONIK SE & Co. KG

Duns Number:315620229

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More Product Details

Catalog Number

429531

Brand Name

Ilivia Neo 7 VR-T

Version/Model Number

429531

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Device Record Status

Public Device Record Key

a6cd0b1f-ddd6-415d-8773-3aae7913b1ff

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTRONIK SE & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 97
3 A medical device with high risk that requires premarket approval 402