Orascoptic - EyeZoom Max Plano - XV1

GUDID 00615375013175

Loupe with plano EyeZoom Max™ oculars on XV1™ frame

METREX RESEARCH, LLC

Surgical binoculars, reusable
Primary Device ID00615375013175
NIH Device Record Keyb8b685a1-7f74-4131-8b86-dd213d37448a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrascoptic - EyeZoom Max Plano - XV1
Version Model NumberEyeZoom Max Plano - XV1
Company DUNS145963778
Company NameMETREX RESEARCH, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com
Phone1.800.369.3698
EmailCustomerCare@Orascoptic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375013175 [Primary]

FDA Product Code

FSPLoupe, Diagnostic/Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

Devices Manufactured by METREX RESEARCH, LLC

00615375013526 - MetriCide 2025-03-31 MetriCide OPA Plus Solution Test Strips - 60 COUNT 2 BOTTLES/CS
00615375014462 - EyeZoom™ Max Rx - Dragonfly™2025-03-24 Dragonfly™ powered loupe with EyeZoom™ Max prescription oculars
00615375001288 - EyeZoom™ Plano - XV1™2025-03-18 XV1™ loupe with EyeZoom™ plano oculars
00615375008669 - HDL™ 5.5 Plano - XV1™2025-03-18 XV1™ loupe with HDL™ 5.5 plano oculars
00615375008683 - EyeZoom™ Mini Plano - XV1™2025-03-18 XV1™ loupe with EyeZoom™ Mini plano oculars
00615375009963 - EyeZoom™ Rx - XV1™2025-03-18 XV1™ loupe with EyeZoom™ prescription oculars
00615375010037 - HDL™ 4.5 Rx - XV1™2025-03-18 XV1™ loupe with HDL™ 4.5 prescription oculars
00615375010051 - HDL™ 5.5 Rx - XV1™2025-03-18 XV1™ loupe with HDL™ 5.5 prescription oculars

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.