Catalog Number

-

Brand Name

Treo

Version/Model Number

4224-644

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

a7162010-73bc-4427-bcd2-cced43f55b41

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10366975000665

Quantity per Package

5

Contains DI Package

00366975000668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case