ELITE 962575000

GUDID 10603295243182

ELITE FEMORAL HEAD +0 9/10 TAPER Diameter 32mm

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295243182
• NIH Device Record Key: 3b261a8f-1f19-414d-a038-f81cef032ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITE
• Version Model Number: 9625-75-000
• Catalog Number: 962575000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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
• 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	10603295243182 [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

On-Brand Devices [ELITE]

• 10603295318118: ELITE FEMORAL HEAD +3 9/10 TAPER Diameter 26mm
• 10603295318101: ELITE FEMORAL HEAD +0 9/10 TAPER Diameter 26mm
• 10603295318095: ELITE FEMORAL HEAD -3 9/10 TAPER Diameter 26mm
• 10603295244295: ELITE FEMORAL HEAD +6 9/10 TAPER Diameter 28mm
• 10603295244134: ELITE FEMORAL HEAD +3 9/10 TAPER Diameter 32mm
• 10603295244110: ELITE FEMORAL HEAD +3 9/10 TAPER Diameter 28mm
• 10603295244073: ELITE FEMORAL HEAD +3 9/10 TAPER Diameter 22.225mm
• 10603295244059: ELITE FEMORAL HEAD -3 9/10 TAPER Diameter 22.225mm
• 10603295243182: ELITE FEMORAL HEAD +0 9/10 TAPER Diameter 32mm
• 10603295243175: ELITE FEMORAL HEAD -3 9/10 TAPER Diameter 32mm
• 10603295243168: ELITE FEMORAL HEAD +0 9/10 TAPER Diameter 28mm
• 10603295243151: ELITE FEMORAL HEAD -3 9/10 TAPER Diameter 28mm
• 10603295243144: ELITE FEMORAL HEAD +0 9/0 TAPER Diameter 22.225mm