00-2358-026-10

GUDID 00889024056961

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00889024056961
• NIH Device Record Key: 64927a21-2d7f-43e2-b5fe-6fa80115a17d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2358-26-10
• Catalog Number: 00-2358-026-10
• 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 138 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024056961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043560

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00889024056961]

Moist Heat or Steam Sterilization

[00889024056961]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-10
• Device Publish Date: 2017-09-28

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