Catalog Number

128600, 128800, 128910

Brand Name

Oto Temp Probe Covers

Version/Model Number

PCT-2500 Disposable Wraps

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

K882949,K882949,K882949,K882949

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

7afe1eee-bda6-4979-a5b8-58a9482eefde

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30834098000328

Quantity per Package

10

Contains DI Package

10834098000324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box