Catalog Number

IMS-1460

Brand Name

Hu-Friedy

Version/Model Number

IMS-1460

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 20, 2022

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K890755

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

6b74ad06-e1ca-40b7-8215-32286c5559be

Public Version Date

January 21, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-