SPY-PHI System

GUDID 20858701006289

SPY-PHI Kit

Novadaq Technologies Inc

General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated
Primary Device ID20858701006289
NIH Device Record Keyf8ca0c26-c8f2-4cff-abed-d08846411aee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPY-PHI System
Version Model NumberHH9001
Company DUNS243730939
Company NameNovadaq Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com
Phone+1(604)232-9861
Emailxx@xx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110858701006282 [Primary]
GS120858701006289 [Package]
Contains: 10858701006282
Package: box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWNConfocal optical imaging

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-06
Device Publish Date2017-03-31

On-Brand Devices [SPY-PHI System]

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