NexGen® Gender Solutions™ 00-5750-016-06

GUDID 00889024191266

Zimmer, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00889024191266
• NIH Device Record Key: 5b5ad46e-f228-4d41-a544-a62134ec20c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen® Gender Solutions™
• Version Model Number: 00-5750-016-06
• Catalog Number: 00-5750-016-06
• 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: 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	00889024191266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060370

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: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-24

On-Brand Devices [NexGen® Gender Solutions™]

• 00889024191303: 00-5750-017-06
• 00889024191297: 00-5750-017-05
• 00889024191280: 00-5750-017-02
• 00889024191273: 00-5750-017-01
• 00889024191266: 00-5750-016-06
• 00889024191259: 00-5750-016-05
• 00889024191242: 00-5750-016-02
• 00889024191235: 00-5750-016-01
• 00889024191228: 00-5750-015-06
• 00889024191211: 00-5750-015-05
• 00889024191204: 00-5750-015-02
• 00889024191198: 00-5750-015-01
• 00889024191181: 00-5750-014-06
• 00889024191174: 00-5750-014-05
• 00889024191150: 00-5750-014-01
• 00889024191143: 00-5750-013-06
• 00889024191129: 00-5750-013-02
• 00889024191167: 00-5750-014-02
• 00889024191136: 00-5750-013-05
• 00889024191112: 00-5750-013-01