Catalog Number

CD1411-36Q

Brand Name

Ellipse™

Version/Model Number

CD1411-36Q

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

NVZ

Product Code Name

Pulse generator, permanent, implantable

Public Device Record Key

facb620a-e4db-4bcc-af48-4f2cea795c23

Public Version Date

February 23, 2022

Public Version Number

9

DI Record Publish Date

February 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-