Universal Flip - Rx

GUDID 00615375010136

Universal Flip loupe with prescription lenses

METREX RESEARCH, LLC

Surgical binoculars, reusable
Primary Device ID00615375010136
NIH Device Record Keyfb2812f8-e391-45d3-a620-c4f18d4f7514
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Flip - Rx
Version Model Number.UNIVERSAL.FLIP.TITAN.ONE-SIZE.*
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 Perscriptiontrue
OTC Over-The-Counterfalse

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

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)

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375010136 [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 Date2025-05-08
Device Publish Date2025-04-30

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00615375013625 - Endeavour™ TruColor™2025-10-03 Endeavour™ TruColor™ headlight system - International, TTL
00615375013632 - Endeavour™ TruColor™2025-10-03 Endeavour™ TruColor™ headlight system - International, FU1
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