802202201

GUDID 00889024498747

Zimmer, Inc.

Metallic femoral head prosthesis

• Primary Device ID: 00889024498747
• NIH Device Record Key: dcc3251f-c93b-49e7-b6f4-c47790266744
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 802202201
• Catalog Number: 802202201
• 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	00889024498747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183457

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

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.

• 00889024674592 - Persona Tibia Cut Block Adapter with 2 Degrees V/V: 2025-01-21
• 00889024674608 - Persona Tibia Cut Block Adapter with 2 Degrees V/V: 2025-01-21
• 00889024682399 - PSN TM TIB DRILL GDE: 2025-01-21
• 00889024684171 - SERIES A PATELLA PROTECTOR ASYMMETRIC 40MM 3PEG: 2025-01-21
• 00889024684188 - SERIES A PATELLA PROTECTOR ASYMMETRIC 34MM 3PEG: 2025-01-21
• 00889024684195 - SERIES A PATELLA PROTECTOR ASYMMETRIC 37MM 3PEG: 2025-01-21
• 00889024684201 - SERIES A PATELLA PROTECTOR ASYMMETRIC 28MM 3PEG: 2025-01-21
• 00889024684218 - SERIES A PATELLA PROTECTOR ASYMMETRIC 31MM 3PEG: 2025-01-21