Flourocsan InSight

GUDID 15420045505773

Hologic, Inc.

Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 15420045505773
• NIH Device Record Key: 4f3223d9-76ab-4528-a2a5-668092ee3ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flourocsan InSight
• Version Model Number: InSight FD
• Company DUNS: 153623137
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505773 [Primary]

FDA Product Code

• OXO: Image-intensified fluoroscopic x-ray system, mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-23

On-Brand Devices [Flourocsan InSight]

• 15420045509634: InSight FD
• 15420045505773: InSight FD