Catalog Number

989803152801

Brand Name

FiberTEMP Fiber Optic Surface Temperature Sensor

Version/Model Number

989803152801

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

11865d23-d9b1-450b-8c42-b0ac0707abfe

Public Version Date

March 11, 2021

Public Version Number

3

DI Record Publish Date

September 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-