HDL Ergo 5.0 Plano

GUDID 00615375013199

HDL Ergo 5.0 Plano

METREX RESEARCH, LLC

Surgical binoculars, reusable

• Primary Device ID: 00615375013199
• NIH Device Record Key: d95fad46-566a-47d9-a0ed-7d2149230fc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDL Ergo 5.0 Plano
• Version Model Number: HDL Ergo 5.0 Plano
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com
• Phone: +18003693698
• Email: customercare@orascoptic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	00615375013199 [Primary]

FDA Product Code

• FSP: Loupe, Diagnostic/Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-15
• Device Publish Date: 2023-11-07

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