iASSIST 302.4001

GUDID 00889024211636

Orthosoft Inc

Robotic surgical navigation system

• Primary Device ID: 00889024211636
• NIH Device Record Key: 4417cf61-e429-4af3-b6ef-18b37ea2287c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iASSIST
• Version Model Number: 302.4001
• Catalog Number: 302.4001
• 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: 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@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024211636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141601

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: 2016-09-14

On-Brand Devices [iASSIST]

• 00889024305496: 20-8011-065-00
• 00889024305489: 20-8011-064-00
• 00889024305472: 20-8011-063-00
• 00889024305250: 20-8011-002-00
• 00889024305243: 20-8011-001-00
• 00889024276185: 20-8000-000-20
• 00889024211636: 302.4001