NexGen® Legacy® Gender Solutions® 00-5761-015-91

GUDID 00889024191976

Zimmer, Inc.

Knee femur prosthesis trial

• Primary Device ID: 00889024191976
• NIH Device Record Key: 0494fb70-bb20-4a28-9c97-17c53816ceac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen® Legacy® Gender Solutions®
• Version Model Number: 00-5761-015-91
• Catalog Number: 00-5761-015-91
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889024191976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031061

FDA Product Code

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

Sterilization

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

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

[00889024191976]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-26
• Device Publish Date: 2016-05-24

On-Brand Devices [NexGen® Legacy® Gender Solutions®]

• 00889024192102: 00-5761-017-92
• 00889024192096: 00-5761-017-91
• 00889024192089: 00-5761-017-82
• 00889024192072: 00-5761-017-81
• 00889024192065: 00-5761-017-02
• 00889024192058: 00-5761-017-01
• 00889024192041: 00-5761-016-92
• 00889024192034: 00-5761-016-91
• 00889024192027: 00-5761-016-82
• 00889024192010: 00-5761-016-81
• 00889024192003: 00-5761-016-02
• 00889024191990: 00-5761-016-01
• 00889024191983: 00-5761-015-92
• 00889024191976: 00-5761-015-91
• 00889024191969: 00-5761-015-82
• 00889024191952: 00-5761-015-81
• 00889024191945: 00-5761-015-02
• 00889024191938: 00-5761-015-01
• 00889024191921: 00-5761-014-92
• 00889024191914: 00-5761-014-91
• 00889024191907: 00-5761-014-82
• 00889024191891: 00-5761-014-81
• 00889024191884: 00-5761-014-02
• 00889024191877: 00-5761-014-01
• 00889024191860: 00-5761-013-92
• 00889024191853: 00-5761-013-91
• 00889024191846: 00-5761-013-82
• 00889024191839: 00-5761-013-81
• 00889024191822: 00-5761-013-02
• 00889024191815: 00-5761-013-01
• 00889024440913: 00-5906-045-02
• 00889024440906: 00-5906-045-01