47-2359-012-26

GUDID 00889024089884

Zimmer, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00889024089884
• NIH Device Record Key: aba27884-9757-4c83-b64f-fafb0e7acee4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 47-2359-012-26
• Catalog Number: 47-2359-012-26
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024089884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070906

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-14
• Device Publish Date: 2015-09-17

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• 00889024693029 - Right 3 Deg Tib Cut Guide Assy: 2025-12-26
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• 00889024703872 - Offset Box Osteotome: 2025-12-26
• 00889024704008 - LB Type 1 Taper Extraction Insert: 2025-12-26
• 00889024704015 - LZ 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704022 - LB 12/14 Taper Extraction Insert: 2025-12-26
• 00889024704039 - Fitmore Extraction Adapter - M: 2025-12-26