OPTIS™ C408661

GUDID 00812059021420

Imaging System

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system

• Primary Device ID: 00812059021420
• NIH Device Record Key: c42a2cf9-aa0b-4d0c-aa19-a977ae1393b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIS™
• Version Model Number: Mobile System
• Catalog Number: C408661
• Company DUNS: 018493531
• Company Name: LIGHTLAB IMAGING, 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812059021420 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-11
• Device Publish Date: 2015-12-21

On-Brand Devices [OPTIS™]

• 00812059021994: Installation Kit
• 00812059021987: Installation Kit
• 00812059021925: Software Upgrade
• 00812059021918: Software Upgrade
• 00812059021444: Tableside Controller
• 00812059021437: Upgrade Kit
• 00812059021420: Imaging System
• 00812059021390: Software Upgrade Kit
• 00812059020126: Mobile Workstation
• 00812059020003: Installation Kit
• 00183739000937: Imaging System