Dragonfly™ C408645

GUDID 00183739000647

Imaging Catheter

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system catheter

• Primary Device ID: 00183739000647
• NIH Device Record Key: 7e46216b-3b33-43b1-8475-fbd3e08ff47e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dragonfly™
• Version Model Number: OPTIS™
• Catalog Number: C408645
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French
• Catheter Gauge: 2.7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DARK, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00183739000647 [Primary]

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-04-20

On-Brand Devices [Dragonfly™]

• 00183739000708: Imaging Catheter
• 00183739000692: Imaging Catheter
• 00183739000654: Imaging Catheter
• 00183739000647: Imaging Catheter
• 00183739000623: Imaging Catheter