Catalog Number

-

Brand Name

ATI, Inc.

Version/Model Number

C-8702

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)

-

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

520f5b54-199d-4cc9-89e9-82f10765f698

Public Version Date

January 06, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2020

Package DI Number

20029431004986

Quantity per Package

10000

Contains DI Package

00029431004982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack