HDL Ergo 5.0 Rx

GUDID 00615375013205

HDL Ergo 5.0 Rx

METREX RESEARCH, LLC

Surgical binoculars, reusable
Primary Device ID00615375013205
NIH Device Record Key91b78dbc-8e20-4a02-8b88-0b6fae864e4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHDL Ergo 5.0 Rx
Version Model NumberHDL Ergo 5.0 Rx
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

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
GS100615375013205 [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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