Disposable Reflective Marker Sphere (DRMS) 41773

GUDID 20805832010012

Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided s

Northern Digital Inc

Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use

• Primary Device ID: 20805832010012
• NIH Device Record Key: acd8ed20-34ee-428b-8204-15b858300c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Reflective Marker Sphere (DRMS)
• Version Model Number: 41773
• Catalog Number: 41773
• 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	00805832010018 [Package]; Package: [30 Units]; In Commercial Distribution
GS1	20805832010012 [Primary]

FDA Product Code

• OLO: Orthopedic 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: 2019-01-11
• Device Publish Date: 2016-09-24

Devices Manufactured by Northern Digital Inc

• 20805832010012 - Disposable Reflective Marker Sphere (DRMS): 2019-01-11Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided s
• 20805832010012 - Disposable Reflective Marker Sphere (DRMS): 2019-01-11 Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical naviga
• 00805832020017 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 00805832020024 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 00805832020031 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 20805832020042 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 20805832030010 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 20805832030027 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image
• 20805832030034 - NDI Passive Spheres: 2018-07-06 Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image