Optimos™ Guidewire GW3-45A

GUDID 08809909404009

The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.

TAEWOONGMEDICAL.CO.,LTD

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• Primary Device ID: 08809909404009
• NIH Device Record Key: 387d009d-ae90-4571-afd6-9109a64b5411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimos™ Guidewire
• Version Model Number: GW3-45A
• Catalog Number: GW3-45A
• Company DUNS: 689484322
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809744979939 [Primary]
GS1	08809909404009 [Package]; Contains: 08809744979939; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic Guidewire, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [Optimos™ Guidewire]

• 08809909404054: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909404047: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909404030: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909404023: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909404016: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909404009: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809909403996: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc
• 08809744979991: The Optimos™ Guidewire is used to provide access to GI tract for the purpose of passing or exc