Catalog Number

IMS-1345

Brand Name

Hu-Friedy

Version/Model Number

IMS-1345

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"

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

K070428,K070428

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

9703b274-d2db-4b75-a8b2-0f53cbbc53a5

Public Version Date

November 06, 2020

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

-