Catalog Number

-

Brand Name

ATI, Inc.

Version/Model Number

C-8786

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)

-

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

43116ae9-0098-4a06-88a8-45c073e15536

Public Version Date

January 06, 2021

Public Version Number

3

DI Record Publish Date

September 30, 2020

Package DI Number

10029431000042

Quantity per Package

100

Contains DI Package

00029431000045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack