Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right 20-8090-004-02

GUDID 00889024563407

Orthosoft Inc

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• Primary Device ID: 00889024563407
• NIH Device Record Key: 45845a40-397f-4056-bb79-25efce7b263b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right
• Version Model Number: 20-8090-004-02
• Catalog Number: 20-8090-004-02
• Company DUNS: 205670032
• Company Name: Orthosoft 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: true
• 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: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com
• Phone: 574-371-3710
• Email: personalizedsolutions@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024563407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190595

FDA Product Code

• QHE: Shoulder Arthroplasty Implantation System

Sterilization

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

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

[00889024563407]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-03
• Device Publish Date: 2019-08-26

Devices Manufactured by Orthosoft Inc

• 00887868557873 - ROSA® Shoulder: 2024-03-14
• 00887868557880 - ROSA® Shoulder: 2024-03-14
• 00887868557897 - ROSA® Shoulder: 2024-03-14
• 00887868557903 - ROSA® Shoulder: 2024-03-14
• 00887868557910 - ROSA® Shoulder: 2024-03-14
• 00887868558078 - ROSA® Shoulder: 2024-03-14
• 00887868558092 - ROSA® Shoulder: 2024-03-14
• 00887868558108 - ROSA® Shoulder: 2024-03-14