Catalog Number

PR-LEAD1

Brand Name

Prelivia Leads

Version/Model Number

PR-LEAD1

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

K210979

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

ddd58f84-ef09-4acc-9b25-a39335a41ee2

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-