Orascoptic - Dragonfly HDL Ergo 3.5

GUDID 00850036373223

Dragonfly™ Powered Loupe with HDL™ Ergo 3.5 Plano Oculars

METREX RESEARCH, LLC

Surgical binoculars, reusable

• Primary Device ID: 00850036373223
• NIH Device Record Key: 565fb1a2-94e6-40e5-8c86-037af23283de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orascoptic - Dragonfly HDL Ergo 3.5
• Version Model Number: Dragonfly HDL Ergo 3.5
• 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: true
• OTC Over-The-Counter: false

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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 *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 *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 *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 *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 *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 *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 *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 *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	00850036373223 [Primary]

FDA Product Code

• FSP: LOUPE, DIAGNOSTIC/SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-25
• Device Publish Date: 2022-12-08

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