NDI Passive Spheres 8801054

GUDID 00805832020031

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.

Northern Digital Inc

Imaging lesion localization marker, external, single-use

• Primary Device ID: 00805832020031
• NIH Device Record Key: 538b1aee-8f68-4c07-90e8-a512e2ee7b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NDI Passive Spheres
• Version Model Number: 8801054
• Catalog Number: 8801054
• Company DUNS: 241987692
• Company Name: Northern Digital 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: true
• 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: 519-884-5142
• Email: spheres@ndigital.com
• Phone: 519-884-5142
• Email: spheres@ndigital.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00805832020031 [Primary]
GS1	20805832020035 [Package]; Package: Tray in Pouch [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033621

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NDI Passive Spheres]

• 20805832040033: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832040026: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832040019: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832030041: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832030034: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832030027: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832030010: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 20805832020042: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 00805832020031: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 00805832020024: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri
• 00805832020017: Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri