101468000

GUDID 10603295001263

TOTAL HIP BALL FEMORAL HEAD Diameter 32mm +5 14/16 TAPER

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis

• Primary Device ID: 10603295001263
• NIH Device Record Key: a7d8b999-1bcb-4158-980b-cd3539421c16
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1014-68-000
• Catalog Number: 101468000
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295001263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853655

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-09-24

Devices Manufactured by DEPUY INTERNATIONAL LTD

• 10603295026860 - PATHWAY: 2024-11-07 PATHWAY DISASSEMBLY DRIVER
• 10603295240501 - CHARNLEY: 2024-11-07 CHARNLEY WEIGHT AND 24 INCHES CHAIN
• 10603295241874 - CHARNLEY: 2024-11-07 CHARNLEY Stem Extra Heavy FLANGED 40 22.225mm OD HEAD CEMENTED
• 10603295241881 - CHARNLEY: 2024-11-07 CHARNLEY STEM FLANGED 40 22.225mm OD HEAD CEMENTED
• 10603295241898 - CHARNLEY: 2024-11-07 CHARNLEY STEM ROUNDBACK 40 22.225MM OD HEAD CEMENTED
• 10603295241904 - CHARNLEY: 2024-11-07 CHARNLEY STEM ROUNDBACK 40 NARROW 22.225mm OD HEAD CEMENTED
• 10603295242208 - CHARNLEY: 2024-11-07 CHARNLEY STEM ROUNDBACK 45 22.225mm OD HEAD CEMENTED
• 10603295242246 - CHARNLEY: 2024-11-07 CHARNLEY STEM FLANGED 45 22.225mm OD HEAD CEMENTED