NA - MARATHON XLPE CEMENTED CUP 38mm TRIAL CUP - DEPUY INTERNATIONAL LTD

Duns Number:896498813

Device Description: MARATHON XLPE CEMENTED CUP 38mm TRIAL CUP

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More Product Details

Catalog Number

962638001

Brand Name

NA

Version/Model Number

9626-38-001

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

4d1f0417-e278-4451-9efb-2c1e35b2cee5

Public Version Date

December 21, 2020

Public Version Number

3

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 INTERNATIONAL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 613
2 A medical device with a moderate to high risk that requires special controls. 72