152190059

GUDID 10603295276647

COBALT CHROME 9/10 FEMORAL HEAD Diameter 28mm +3 9/10 TAPER

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis
Primary Device ID10603295276647
NIH Device Record Keycdae16fc-1635-48f8-919d-fd7b319d0351
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1521-90-059
Catalog Number152190059
Company DUNS896498813
Company NameDEPUY INTERNATIONAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295276647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-09-24

Devices Manufactured by DEPUY INTERNATIONAL LTD

10603295026860 - PATHWAY2024-11-07 PATHWAY DISASSEMBLY DRIVER
10603295240501 - CHARNLEY2024-11-07 CHARNLEY WEIGHT AND 24 INCHES CHAIN
10603295241874 - CHARNLEY2024-11-07 CHARNLEY Stem Extra Heavy FLANGED 40 22.225mm OD HEAD CEMENTED
10603295241881 - CHARNLEY2024-11-07 CHARNLEY STEM FLANGED 40 22.225mm OD HEAD CEMENTED
10603295241898 - CHARNLEY2024-11-07 CHARNLEY STEM ROUNDBACK 40 22.225MM OD HEAD CEMENTED
10603295241904 - CHARNLEY2024-11-07 CHARNLEY STEM ROUNDBACK 40 NARROW 22.225mm OD HEAD CEMENTED
10603295242208 - CHARNLEY2024-11-07 CHARNLEY STEM ROUNDBACK 45 22.225mm OD HEAD CEMENTED
10603295242246 - CHARNLEY2024-11-07 CHARNLEY STEM FLANGED 45 22.225mm OD HEAD CEMENTED

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