CARDINAL HEALTH - TOTAL HIP PACK - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: TOTAL HIP PACK

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More Product Details

Catalog Number

SOP34HPINF

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP34HPINF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

OJH

Product Code Name

Orthopedic tray

Device Record Status

Public Device Record Key

d8339dd8-f490-4ce3-8545-aef6bd66fcf0

Public Version Date

July 23, 2018

Public Version Number

1

DI Record Publish Date

June 20, 2018

Additional Identifiers

Package DI Number

50887488999584

Quantity per Package

2

Contains DI Package

10887488999586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40