00-2347-125-45

GUDID 00889024053656

Zimmer, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889024053656
• NIH Device Record Key: 2e5bdde7-a182-4c90-a081-4cc34b045871
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2347-125-45
• Catalog Number: 00-2347-125-45
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Length: 145 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024053656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142579

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

[00889024053656]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-17
• Device Publish Date: 2015-10-09

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• 00889024678767 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678774 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678781 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678798 - OsseoFit™ Stemless Shoulder: 2024-12-26
• 00889024678804 - OsseoFit™ Stemless Shoulder: 2024-12-26