HDL Ergo 5.0 Plano - Dragonfly

GUDID 00615375013212

HDL Ergo 5.0 Plano - Dragonfly

METREX RESEARCH, LLC

Surgical binoculars, reusable
Primary Device ID00615375013212
NIH Device Record Key639c26f1-b0fd-4ac3-8fdf-febf751a54be
Commercial Distribution StatusIn Commercial Distribution
Brand NameHDL Ergo 5.0 Plano - Dragonfly
Version Model NumberHDL Ergo 5.0 Plano - Dragonfly
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

Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com
Phone+18003693698
Emailcustomercare@orascoptic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375013212 [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 Date2023-11-15
Device Publish Date2023-11-07

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