Catalog Number

-

Brand Name

Myocardial Needle Temperature Probe

Version/Model Number

2124

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K813459,K813459

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

57bb96a1-9d6e-43e5-b800-1cd42e8217c3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

B04021242O

Quantity per Package

1

Contains DI Package

B04021241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-