PERSONA™ Vivacit-E® 42-5126-002-13

GUDID 00889024237735

Zimmer, Inc.

Tibial insert

• Primary Device ID: 00889024237735
• NIH Device Record Key: 486d7cb1-368e-4d4b-b451-a76a81d2ec31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONA™ Vivacit-E®
• Version Model Number: 42-5126-002-13
• Catalog Number: 42-5126-002-13
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024237735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123459

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 4
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-08-08

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

• 00889024243262: 42-5222-007-20
• 00889024243255: 42-5222-007-18
• 00889024243248: 42-5222-007-16
• 00889024243231: 42-5222-007-14
• 00889024243224: 42-5222-007-13
• 00889024243217: 42-5222-007-12
• 00889024243200: 42-5222-007-11
• 00889024243194: 42-5222-007-10
• 00889024243187: 42-5222-006-20
• 00889024243170: 42-5222-006-18
• 00889024243163: 42-5222-006-16
• 00889024243156: 42-5222-006-14
• 00889024243149: 42-5222-006-13
• 00889024243132: 42-5222-006-12
• 00889024243125: 42-5222-006-11
• 00889024243118: 42-5222-006-10
• 00889024243101: 42-5222-005-20
• 00889024243095: 42-5222-005-18
• 00889024243088: 42-5222-005-16
• 00889024243071: 42-5222-005-14
• 00889024243064: 42-5222-005-13
• 00889024243057: 42-5222-005-12
• 00889024243040: 42-5222-005-11
• 00889024243033: 42-5222-005-10
• 00889024243026: 42-5222-004-20
• 00889024243019: 42-5222-004-18
• 00889024243002: 42-5222-004-16
• 00889024242999: 42-5222-004-14
• 00889024242982: 42-5222-004-13
• 00889024242975: 42-5222-004-12
• 00889024242968: 42-5222-004-11
• 00889024242951: 42-5222-004-10
• 00889024242944: 42-5222-003-20
• 00889024242937: 42-5222-003-18
• 00889024242920: 42-5222-003-16
• 00889024242913: 42-5222-003-14
• 00889024242906: 42-5222-003-13
• 00889024242890: 42-5222-003-12
• 00889024242883: 42-5222-003-11
• 00889024242876: 42-5222-003-10
• 00889024242869: 42-5222-002-20
• 00889024242852: 42-5222-002-18
• 00889024242845: 42-5222-002-16
• 00889024242838: 42-5222-002-14
• 00889024242821: 42-5222-002-13
• 00889024242814: 42-5222-002-12
• 00889024242807: 42-5222-002-11
• 00889024242791: 42-5222-002-10
• 00889024242784: 42-5222-001-20
• 00889024242777: 42-5222-001-18