Catalog Number

77-352

Brand Name

Rexall

Version/Model Number

77-352

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041516,K041516,K041516

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ac59ea98-b17a-4622-a5a3-d20f59bbb6cc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10845717090008

Quantity per Package

72

Contains DI Package

30845717090002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master