ROSA®

GUDID 00889024594012

Orthosoft Inc

Osteotomy guide, reusable

• Primary Device ID: 00889024594012
• NIH Device Record Key: d68c324e-505c-45f8-8848-377d82c581bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROSA®
• Version Model Number: 20-8020-033-00
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024594012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210121

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

[00889024594012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

On-Brand Devices [ROSA®]

• 00889024584426: 20-8020-029-00
• 00889024584419: 20-8020-028-00
• 00889024594029: 20-8020-034-00
• 00889024594012: 20-8020-033-00
• 00889024594005: 20-8020-032-00
• 00889024593992: 20-8020-031-00
• 00889024593985: 20-8020-030-00
• 70887868552143: 20-8020-160-00
• 70887868552136: 20-8020-159-00
• 70887868552129: 20-8020-158-00