Catalog Number

-

Brand Name

SEG

Version/Model Number

HTD8216C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 2021

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

K180385,K180385

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

cb3924d9-4263-40cb-a535-4867f5410383

Public Version Date

July 07, 2021

Public Version Number

2

DI Record Publish Date

June 09, 2021

Package DI Number

16970289035301

Quantity per Package

40

Contains DI Package

06970289035304

Package Discontinue Date

July 07, 2021

Package Status

Not in Commercial Distribution

Package Type

-