Catalog Number

-

Brand Name

LATITUDE® NXT

Version/Model Number

6460

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P910077,P910077,P910077,P910077,P910077

Product Code

OSR

Product Code Name

Pacemaker/icd/crt non-implanted components

Public Device Record Key

c6859296-4346-4794-80bf-6032e01bd07c

Public Version Date

September 24, 2021

Public Version Number

5

DI Record Publish Date

July 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-