Persona® Vivacit-E®

GUDID 00880304818439

Biomet Orthopedics, LLC

Unicondylar knee insert

• Primary Device ID: 00880304818439
• NIH Device Record Key: 1164fac6-a4dc-453b-9605-293a47468010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persona® Vivacit-E®
• Version Model Number: 42-5182-007-10
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• Email: customerservice@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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304818439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161592

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, 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: 2018-07-06
• Device Publish Date: 2016-12-09

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

• 00880304818767: 42-5282-009-14
• 00880304818750: 42-5282-009-12
• 00880304818743: 42-5282-009-11
• 00880304818736: 42-5282-009-10
• 00880304818729: 42-5282-009-09
• 00880304818712: 42-5282-009-08
• 00880304818705: 42-5182-009-14
• 00880304818699: 42-5182-009-12
• 00880304818682: 42-5182-009-11
• 00880304818675: 42-5182-009-10
• 00880304818668: 42-5182-009-09
• 00880304818651: 42-5182-009-08
• 00880304818644: 42-5282-008-14
• 00880304818637: 42-5282-008-12
• 00880304818620: 42-5282-008-11
• 00880304818613: 42-5282-008-10
• 00880304818606: 42-5282-008-09
• 00880304818590: 42-5282-008-08
• 00880304818583: 42-5182-008-14
• 00880304818576: 42-5182-008-12
• 00880304818569: 42-5182-008-11
• 00880304818552: 42-5182-008-10
• 00880304818545: 42-5182-008-09
• 00880304818538: 42-5182-008-08
• 00880304818521: 42-5282-007-14
• 00880304818514: 42-5282-007-12
• 00880304818507: 42-5282-007-11
• 00880304818491: 42-5282-007-10
• 00880304818484: 42-5282-007-09
• 00880304818477: 42-5282-007-08
• 00880304818460: 42-5182-007-14
• 00880304818453: 42-5182-007-12
• 00880304818446: 42-5182-007-11
• 00880304818439: 42-5182-007-10
• 00880304818422: 42-5182-007-09
• 00880304818415: 42-5182-007-08
• 00880304818408: 42-5282-006-14
• 00880304818392: 42-5282-006-12
• 00880304818385: 42-5282-006-11
• 00880304818378: 42-5282-006-10
• 00880304818361: 42-5282-006-09
• 00880304818354: 42-5282-006-08
• 00880304818347: 42-5182-006-14
• 00880304818330: 42-5182-006-12
• 00880304818323: 42-5182-006-11
• 00880304818316: 42-5182-006-10
• 00880304818309: 42-5182-006-09
• 00880304818293: 42-5182-006-08
• 00880304818286: 42-5282-005-14
• 00880304818279: 42-5282-005-12