Avenir SSI004397

GUDID 00889024512405

Zimmer, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889024512405
• NIH Device Record Key: e5c874f8-360a-4c5f-870f-47ce8385d6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenir
• Version Model Number: SSI004397
• Catalog Number: SSI004397
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024512405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123392

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

[00889024512405]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-14
• Device Publish Date: 2018-07-26

Devices Manufactured by Zimmer, Inc.

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• 00887868139628 - Affixus®: 2024-11-18
• 00887868139635 - Affixus®: 2024-11-18
• 00887868139642 - Affixus®: 2024-11-18
• 00887868139659 - Affixus®: 2024-11-18
• 00887868139666 - Affixus®: 2024-11-18
• 00887868139673 - Affixus®: 2024-11-18
• 00887868139680 - Affixus®: 2024-11-18