Catalog Number

429570

Brand Name

Intica Neo 5 VR-T

Version/Model Number

429570

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

5ff9911d-6760-4b91-8646-b2569505d8ef

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-