ClearCap Distal Attachment FM-CC02

GUDID 18809327356147

Conical Cap Ø11.8mm

FINEMEDIX CO.,LTD.

Endoscope distal observation spacer, single-use

• Primary Device ID: 18809327356147
• NIH Device Record Key: a6447896-713e-4189-b1b8-d1486960c5d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCap Distal Attachment
• Version Model Number: FM-CC02
• Catalog Number: FM-CC02
• Company DUNS: 688256864
• Company Name: FINEMEDIX CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	08809327356140 [Primary]
GS1	18809327356147 [Package]; Contains: 08809327356140; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242134

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

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: 2026-04-01
• Device Publish Date: 2026-03-24

On-Brand Devices [ClearCap Distal Attachment]

• 18809327352859: 14mm/11.6mm
• 18809327352842: 13.4mm/11mm
• 18809327352835: 12.4mm/10mm
• 18809327352828: 11.35mm/8.9mm
• 18809327352811: 11.8mm/9.4mm
• 18809327352804: 15mm/12.6mm
• 18809327350633: 15.7mm/13.3mm
• 18809327356192: Conical Cap Ø15.7mm
• 18809327356185: Conical Cap Ø14mm
• 18809327356178: Conical Cap Ø13.4mm
• 18809327356161: Conical Cap Ø12.4mm
• 18809327356154: Conical Cap Ø11.35mm
• 18809327356147: Conical Cap Ø11.8mm
• 18809327356130: Conical Cap Ø15mm