Shoulder Pure Planning 20-8090-007-00

GUDID 00889024563438

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00889024563438
• NIH Device Record Key: 9ccb16a6-5dd9-43e5-add0-bd03e3213d1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Pure Planning
• Version Model Number: 20-8090-007-00
• Catalog Number: 20-8090-007-00
• 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	00889024563438 [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

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

Moist Heat or Steam Sterilization

[00889024563438]

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

• 00887868578915 - HAMMR™: 2024-05-01
• 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