ARTICUL/EZE 136529000

GUDID 10603295033349

ARTICUL/EZE FEMORAL HEAD Diameter 22.225mm +4 12/14 TAPER

DEPUY ORTHOPAEDICS, INC.

Metallic femoral head prosthesis

• Primary Device ID: 10603295033349
• NIH Device Record Key: 0959ff6b-41f0-4d33-b9aa-fd1a93346afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTICUL/EZE
• Version Model Number: 1365-29-000
• Catalog Number: 136529000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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	10603295033349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980513

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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]

• 10603295034292: Articul/eze M-Spec FEMORAL HEAD Diameter 48mm +8.5 Offset 12/14 TAPER
• 10603295033974: ARTICUL/EZE METAL ON METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +12
• 10603295033356: ARTICUL/EZE FEMORAL HEAD Diameter 22.225mm +7 12/14 TAPER
• 10603295033349: ARTICUL/EZE FEMORAL HEAD Diameter 22.225mm +4 12/14 TAPER
• 10603295099130: M-SPEC ARTICUL/EZE 12/14 TRAY 40/44/48