Nexel 82-0180-133-01

GUDID 00887868226991

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00887868226991
• NIH Device Record Key: 85ff2663-4794-472f-a61f-8a161d46e3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexel
• Version Model Number: 82-0180-133-01
• Catalog Number: 82-0180-133-01
• 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: false
• Serial Number: true
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868226991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123862

FDA Product Code

• JDC: Prosthesis, Elbow, Constrained, Cemented

Sterilization

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

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

[00887868226991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

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• 00889024658165 - Persona® Knee System: 2025-02-14
• 00889024658172 - Persona® Knee System: 2025-02-14
• 00889024658189 - Persona® Knee System: 2025-02-14
• 00889024658196 - Persona® Knee System: 2025-02-14
• 00889024658202 - Persona® Knee System: 2025-02-14