802203605

GUDID 00889024498914

Zimmer, Inc.

Metallic femoral head prosthesis

• Primary Device ID: 00889024498914
• NIH Device Record Key: a2bea9a0-8f56-49a3-a365-5f93ca3e2ebb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 802203605
• Catalog Number: 802203605
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024498914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183457

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-27
• Device Publish Date: 2020-03-19

Devices Manufactured by Zimmer, Inc.

• 00887868575457 - Z1™ Hip System: 2024-09-17
• 00887868575464 - Z1™ Hip System: 2024-09-17
• 00887868575471 - Z1™ Hip System: 2024-09-17
• 00887868575488 - Z1™ Hip System: 2024-09-17
• 00887868575495 - Z1™ Hip System: 2024-09-17
• 00887868575501 - Z1™ Hip System: 2024-09-17
• 00887868575518 - Z1™ Hip System: 2024-09-17
• 00887868575525 - Z1™ Hip System: 2024-09-17