Spark TruColor

GUDID 00615375013274

FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, EUROPE

METREX RESEARCH, LLC

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• Primary Device ID: 00615375013274
• NIH Device Record Key: b13b9f64-8999-4e33-968a-9654fa283cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spark TruColor
• Version Model Number: 910174-21
• 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
• 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 (-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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	00615375013274 [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: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [Spark TruColor]

• 00615375013328: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, AUSTRALIA w/SOFT CASE
• 00615375013311: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, AUSTRALIA
• 00615375013304: FINAL ASSEMBLY, SPARK™, TRUCOLOR, TTL, UNITED KINGDOM w/SOFT CASE
• 00615375013298: FINAL ASSEMBLY, SPARK™TRUCOLOR, TTL, UNITED KINGDOM
• 00615375013281: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, EUROPE w/SOFT CASE
• 00615375013274: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, EUROPE
• 00615375013267: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN w/SOFT CASE
• 00615375013250: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN
• 00615375013243: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, NORTH AMERICA w/SOFT CASE
• 00615375013236: FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, NORTH AMERICA