FL400 / FL560

GUDID 07630003579482

FL400 / FL560 for M530 - Accessory for Leica surgical operating microscope systems

Leica Microsystems (Schweiz) AG

Surgical microscope fluorescent angiography system

• Primary Device ID: 07630003579482
• NIH Device Record Key: 610c8362-68db-45b8-8a67-ef7e7ad4c5c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FL400 / FL560
• Version Model Number: 000000000010448796
• Company DUNS: 480198725
• Company Name: Leica Microsystems (Schweiz) AG
• 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(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com
• Phone: +1(847)8213502
• Email: Andrew.Suchomski@leica-microsystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630003579482 [Primary]

FDA Product Code

• IZI: System, x-ray, angiographic

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: 2020-09-22
• Device Publish Date: 2020-09-14

Devices Manufactured by Leica Microsystems (Schweiz) AG

• 07630003501612 - M320 Optics Carrier: 2024-09-09 M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12
• 07630802402615 - GLOW800: 2024-05-13 GLOW800 - Accessory for Leica surgical operating microscope systems
• 07630802402622 - ARveo 8: 2024-05-13 ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8
• 07630802403810 - MyVeo: 2024-05-13 MyVeo - Complete device including the Connection Hub, all Connection Cables and one MyVeo Headset
• 07630802403827 - MyVeo Headset: 2024-05-10 MyVeo Headset - additional Headset to MyVeo Connection Hub
• 07630003567717 - RUV800 WD175: 2022-08-29 RUV800 WD175 - Accessory for Leica surgical operating microscope systems
• 07630003567724 - Leica RUV800 WD200: 2022-08-29 RUV800 WD200 - Accessory for Leica surgical operating microscope systems
• 07630003599008 - PROVEO 8 F42: 2022-04-08 PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope system: PROVEO 8