Catalog Number

SOP19SPCHL

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP19SPCHL

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OJH

Product Code Name

Orthopedic tray

Public Device Record Key

cb260b09-8287-4a37-9fc3-103455a14cf4

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2015

Package DI Number

50887488000051

Quantity per Package

3

Contains DI Package

00887488000056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE