DURALOC - Duraloc OPTION CUP Enduron Liner LPW 28mmID 54 OR - DEPUY INTERNATIONAL LTD

Duns Number:896498813

Device Description: Duraloc OPTION CUP Enduron Liner LPW 28mmID 54 OR 56mmOD

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More Product Details

Catalog Number

159923054

Brand Name

DURALOC

Version/Model Number

1599-23-054

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

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

K040544

Product Code Details

Product Code

LPH

Product Code Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Record Status

Public Device Record Key

07200b6a-fdf8-4ac5-a4a2-a2ddef61e98f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

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