Endeavour MD

GUDID 00615375013397

FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, NORTH AMERICA, TTL

METREX RESEARCH, LLC

Surgical binoculars, reusable
Primary Device ID00615375013397
NIH Device Record Keye43a10b3-27f6-4d4e-8fc4-a2bffde76acd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndeavour MD
Version Model Number910176-1
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 Usetrue
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
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)
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
GS100615375013397 [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 Date2023-11-21
Device Publish Date2023-11-13

On-Brand Devices [Endeavour MD]

00615375013441FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, JAW
00615375013434FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, UNIVERSAL
00615375013427FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, TTL
00615375013410FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, NORTH AMERICA, JAW
00615375013403FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, NORTH AMERICA, UNIVERSAL
00615375013397FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, NORTH AMERICA, TTL
00615375013380FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, JAW
00615375013373FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, UNIVERSAL
00615375013366FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, TTL
00615375013359FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, JAW
00615375013342FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, UNIVERSAL
00615375013335FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, TTL

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