BiglianiFlatow®

GUDID 00889024379688

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024379688
• NIH Device Record Key: a0977ccb-9760-453c-a014-b067dcd42ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiglianiFlatow®
• Version Model Number: 4301-35-01
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 2
• 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@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024264861 [Primary]
GS1	00889024379688 [Package]; Contains: 00889024264861; Package: [36 Units]; In Commercial Distribution
GS1	00889024466395 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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: 2019-04-08
• Device Publish Date: 2016-08-09

Devices Manufactured by Zimmer, Inc.

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• 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