ELITE PLUS 962529000

GUDID 10603295242888

ELITE PLUS FEMORAL HEAD Diameter 22.225mm +6 9/10 TAPER

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis

• Primary Device ID: 10603295242888
• NIH Device Record Key: 968d210f-7337-43c2-b8d9-dcc275286233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE PLUS
• Version Model Number: 9625-29-000
• Catalog Number: 962529000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295242888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871867

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

• 10603295235958 - C-STEM: 2024-02-08 C-STEM END CAP
• 10603295235682 - C-STEM: 2024-02-05 C-STEM VOID CENTRALISER 10mm
• 10603295235736 - C-STEM: 2024-02-05 C-STEM VOID CENTRALISER 12mm
• 10603295235811 - C-STEM: 2024-02-05 C-STEM VOID CENTRALISER 14mm
• 10603295235873 - C-STEM: 2024-02-05 C-STEM VOID CENTRALISER 16mm
• 10603295235897 - C-STEM: 2024-02-05 C-STEM VOID CENTRALISER 18mm
• 10603295236351 - C-STEM: 2024-02-05 C-STEM CENTRALISER
• 10603295026969 - PATHWAY: 2023-10-27 PATHWAY TIBIAL SCREW 21mm