Catalog Number

CI-DHI

Brand Name

Mesa Labs Dry Heat Indicator Labels

Version/Model Number

CI-DHI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K953122,K953122,K953122

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

dccca09e-70ac-495e-a3c0-34f5f49e245c

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 30, 2016

Package DI Number

M985CIDHI2

Quantity per Package

100

Contains DI Package

M985CIDHI1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case