Sesamoid 20-8000-070-64

GUDID 00889024305205

Orthosoft Inc

Robotic surgical navigation system

• Primary Device ID: 00889024305205
• NIH Device Record Key: b702192c-f7a5-44a8-9a87-0fc6b9c21490
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sesamoid
• Version Model Number: 20-8000-070-64
• Catalog Number: 20-8000-070-64
• 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: 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@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024305205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030827

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Sesamoid]

• 00889024489165: 20-8000-070-48
• 00889024305205: 20-8000-070-64
• 00889024305120: 20-8000-070-39
• 00889024305113: 20-8000-070-38
• 00889024305106: 20-8000-070-37
• 00889024305090: 20-8000-070-36
• 00889024305083: 20-8000-070-35