ClearTip

GUDID 18809327352958

EUS-FNB 19G

FINEMEDIX CO.,LTD.

Flexible endoscopic biopsy handpiece/needle

• Primary Device ID: 18809327352958
• NIH Device Record Key: aa7f8ab8-619b-47d3-9cfb-8328869ef0a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearTip
• Version Model Number: FM-CTB001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809327352951 [Primary]
GS1	18809327352958 [Package]; Contains: 08809327352951; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180363

FDA Product Code

• FCG: Biopsy Needle

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: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [ClearTip]

• 18809327352972: EUS-FNB 25G
• 18809327352965: EUS-FNB 22G
• 18809327352958: EUS-FNB 19G
• 18809327352941: EUS-FNA 25G
• 18809327352934: EUS-FNA 22G
• 18809327352927: EUS-FNA 19G