ARTICUL/EZE 136514000

GUDID 10603295033127

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

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis

• Primary Device ID: 10603295033127
• NIH Device Record Key: 9e9175f8-380e-497a-9c32-54d458c7b624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTICUL/EZE
• Version Model Number: 1365-14-000
• Catalog Number: 136514000
• 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	10603295033127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• 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