SPY-PHI System

GUDID 20858701006289

SPY-PHI Kit

Novadaq Technologies Inc

General surgical procedure kit, medicated

• Primary Device ID: 20858701006289
• NIH Device Record Key: f8ca0c26-c8f2-4cff-abed-d08846411aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPY-PHI System
• Version Model Number: HH9001
• Company DUNS: 243730939
• Company Name: Novadaq Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com
• Phone: +1(604)232-9861
• Email: xx@xx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10858701006282 [Primary]
GS1	20858701006289 [Package]; Contains: 10858701006282; Package: box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190729

FDA Product Code

• OWN: Confocal optical imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-06
• Device Publish Date: 2017-03-31

On-Brand Devices [SPY-PHI System]

• 00858701006193: SPY-PHI Portable Handheld Imaging System
• 20858701006289: SPY-PHI Kit
• 20858701006326: SPY-PHI drape