Catalog Number

-

Brand Name

Screwdriver

Version/Model Number

Reply/Esprit

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

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

P950029

Product Code

NVZ

Product Code Name

Pulse generator, permanent, implantable

Public Device Record Key

864029ff-e6c3-443b-b014-fe8e6eb4f019

Public Version Date

October 20, 2020

Public Version Number

4

DI Record Publish Date

September 05, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-