ARTICUL/EZE 136515000

GUDID 10603295033134

ARTICUL/EZE FEMORAL HEAD Diameter 28mm +15.5 12/14 TAPER

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis

• Primary Device ID: 10603295033134
• NIH Device Record Key: 7750b214-a894-4cb6-bda1-43576c937693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTICUL/EZE
• Version Model Number: 1365-15-000
• Catalog Number: 136515000
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295033134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843909
• Premarket Notification: K883460

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 [ARTICUL/EZE]

• 10603295033134: ARTICUL/EZE FEMORAL HEAD Diameter 28mm +15.5 12/14 TAPER
• 10603295033127: ARTICUL/EZE FEMORAL HEAD Diameter 28mm +12 12/14 TAPER
• 10603295033103: ARTICUL/EZE FEMORAL HEAD Diameter 28mm +8.5 12/14 TAPER
• 10603295033080: ARTICUL/EZE FEMORAL HEAD Diameter 28mm +5 12/14 TAPER
• 10603295033066: ARTICUL/EZE FEMORAL HEAD Diameter 28mm +1.5 12/14 TAPER