NvisionVLE Marking Console with IRIS, Upgraded

GUDID 00859591006263

NINEPOINT MEDICAL, INC.

Endoscopic optical coherence tomography system

• Primary Device ID: 00859591006263
• NIH Device Record Key: 98782375-8edc-4cff-a33b-5d4dd4f7ffab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NvisionVLE Marking Console with IRIS, Upgraded
• Version Model Number: 94301-MI-UPG
• Company DUNS: 961880999
• Company Name: NINEPOINT MEDICAL, 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: false
• Serial Number: true
• 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: 855-900-7202
• Email: customerservice@ninepointmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859591006263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182616

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-11-09

Devices Manufactured by NINEPOINT MEDICAL, INC.

• 00859591006232 - NvisionVLE Inflation Kit: 2020-05-06
• 00859591006249 - NvisionVLE Marking Console with IRIS: 2018-12-10
• 00859591006256 - NvisionVLE Marking Console with IRIS, Refurbished: 2018-12-10
• 00859591006263 - NvisionVLE Marking Console with IRIS, Upgraded: 2018-12-10
• 00859591006263 - NvisionVLE Marking Console with IRIS, Upgraded: 2018-12-10
• 00859591006270 - NvisionVLE Marking Console with IRIS, Upgraded, Refurbished: 2018-12-10
• 00859591006027 - NvisionVLE Imaging Probe 14mm: 2018-07-06
• 00859591006034 - NvisionVLE Imaging Probe 17mm: 2018-07-06
• 00859591006041 - NvisionVLE Imaging Probe 20mm: 2018-07-06