ZIMMER - ZIMMER HUDSON/HUDSON ADAPTOR - DEPUY ORTHOPAEDICS, INC.

Duns Number:080506581

Device Description: ZIMMER HUDSON/HUDSON ADAPTOR

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More Product Details

Catalog Number

244300000

Brand Name

ZIMMER

Version/Model Number

2443-00-000

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

HWE

Product Code Name

INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Device Record Status

Public Device Record Key

588f81b3-ef59-4fc5-94b1-043a713a6b3f

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY ORTHOPAEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5254
2 A medical device with a moderate to high risk that requires special controls. 4003
3 A medical device with high risk that requires premarket approval 908