PERSONA® Vivacit-E®

GUDID 00889024468030

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024468030
• NIH Device Record Key: a83ed728-c5b9-40ab-81e2-c0b8b1de9d4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA® Vivacit-E®
• Version Model Number: 42-5221-003-12
• 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@zimmer.com

Device Dimensions

• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024468030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150090

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-08-22

On-Brand Devices [PERSONA® Vivacit-E®]

• 00889024555747: 42-5228-011-26
• 00889024555730: 42-5228-011-24
• 00889024555723: 42-5228-011-22
• 00889024555716: 42-5228-011-20
• 00889024555709: 42-5228-011-18
• 00889024555693: 42-5228-011-16
• 00889024555686: 42-5228-011-14
• 00889024555679: 42-5228-011-12
• 00889024555662: 42-5228-011-10
• 00889024555655: 42-5228-010-26
• 00889024555648: 42-5228-010-24
• 00889024555631: 42-5228-010-22
• 00889024555624: 42-5228-010-20
• 00889024555617: 42-5228-010-18
• 00889024555600: 42-5228-010-16
• 00889024555594: 42-5228-010-14
• 00889024555587: 42-5228-010-12
• 00889024555570: 42-5228-010-10
• 00889024555563: 42-5228-009-26
• 00889024555556: 42-5228-009-24
• 00889024555549: 42-5228-009-22
• 00889024555532: 42-5228-009-20
• 00889024555525: 42-5228-009-18
• 00889024555518: 42-5228-009-16
• 00889024555501: 42-5228-009-14
• 00889024555495: 42-5228-009-12
• 00889024555488: 42-5228-009-10
• 00889024555471: 42-5228-008-26
• 00889024555464: 42-5228-008-24
• 00889024555457: 42-5228-008-22
• 00889024555440: 42-5228-008-20
• 00889024555433: 42-5228-008-18
• 00889024555426: 42-5228-008-16
• 00889024555419: 42-5228-008-14
• 00889024555402: 42-5228-008-12
• 00889024555396: 42-5228-008-10
• 00889024555389: 42-5228-007-26
• 00889024555372: 42-5228-007-24
• 00889024555365: 42-5228-007-22
• 00889024555358: 42-5228-007-20
• 00889024555341: 42-5228-007-18
• 00889024555334: 42-5228-007-16
• 00889024555327: 42-5228-007-14
• 00889024555310: 42-5228-007-12
• 00889024555303: 42-5228-007-10
• 00889024555297: 42-5228-006-26
• 00889024555280: 42-5228-006-24
• 00889024555273: 42-5228-006-22
• 00889024555266: 42-5228-006-20
• 00889024555259: 42-5228-006-18