PTEYE

GUDID 00763000497163

CONSOLE PTEYE-RF REFURBISHED

MEDTRONIC XOMED, INC.

Intraoperative parathyroid detection system control unit
Primary Device ID00763000497163
NIH Device Record Keyd4e1ccff-3bee-4e01-aea1-ef773d6e8144
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTEYE
Version Model NumberPTEYE-RF
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000497163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDFParathyroid autofluorescence detection device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-05
Device Publish Date2023-11-27

On-Brand Devices [PTEYE]

00763000497057PROBE PTEYE-1 FIBER OPTIC
00763000497040CONSOLE PTEYE
00763000497163CONSOLE PTEYE-RF REFURBISHED

Trademark Results [PTEYE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PTEYE
PTEYE
88911798 not registered Live/Pending
AI BIOMED CORP.
2020-05-12

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