ClearCap Distal Attachment

GUDID 18809327352811

11.8mm/9.4mm

FINEMEDIX CO.,LTD.

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• Primary Device ID: 18809327352811
• NIH Device Record Key: 7cfdd44d-a0ab-4b55-974f-c93e0151bf80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCap Distal Attachment
• Version Model Number: FM-EC0002
• 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: 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
• 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
• 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	08809327352814 [Primary]
GS1	18809327352811 [Package]; Contains: 08809327352814; Package: Box [10 Units]; In Commercial Distribution
GS1	28809327352818 [Package]; Contains: 08809327352814; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202616

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: 2021-03-19
• Device Publish Date: 2021-03-11

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