Catalog Number

2247700

Brand Name

SigmaPace 1000

Version/Model Number

SIGMAP1K-USA120V

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

K011729

Product Code

DTC

Product Code Name

Analyzer, Pacemaker Generator Function

Public Device Record Key

14b7a0b2-02dd-4045-a8f4-67589821a15b

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-