Catalog Number

-

Brand Name

AEON

Version/Model Number

A201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 24, 2018

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171578,K171578

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

216159fb-473f-4e5a-b3c1-c8736aacde95

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

November 23, 2018

Package DI Number

36947832500092

Quantity per Package

100

Contains DI Package

06947832500046

Package Discontinue Date

November 23, 2018

Package Status

Not in Commercial Distribution

Package Type

-