ClearEndoclip

GUDID 18809327353092

11mm/90°/2300mm

FINEMEDIX CO.,LTD.

Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 18809327353092
• NIH Device Record Key: 06c1a20b-14ac-4995-a83f-53c1d223ac84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearEndoclip
• Version Model Number: FM-CLD11-090(2300)
• Company DUNS: 688256864
• Company Name: FINEMEDIX CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com
• Phone: +82537418388
• Email: finemedix@finemedix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809327353095 [Primary]
GS1	18809327353092 [Package]; Contains: 08809327353095; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200217

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

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: 2020-10-27
• Device Publish Date: 2020-10-19

On-Brand Devices [ClearEndoclip]

• 18809327353092: 11mm/90°/2300mm
• 18809327353085: 11mm/90°/1650mm