Catalog Number

-

Brand Name

FLENTS

Version/Model Number

67118

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

Yes

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

-

Product Code

KPD

Product Code Name

Strip, Temperature, Forehead, Liquid Crystal

Public Device Record Key

cb2cb06d-9467-4063-8e14-e9b1fe2ff435

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 06, 2016

Package DI Number

20025715671189

Quantity per Package

6

Contains DI Package

00025715671185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG