Spark TruColor

GUDID 00615375013250

FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN

METREX RESEARCH, LLC

Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable Surgical binoculars, reusable

• Primary Device ID: 00615375013250
• NIH Device Record Key: 43afcfb4-405a-4b88-a6fe-3d35d1f3cb7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spark TruColor
• Version Model Number: 910174-11
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375013250 [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