Clear-Jet Injection Catheter

GUDID 08809327352432

23G-6mm/ 0.1T/ 2,300mm

FINEMEDIX CO.,LTD.

General-purpose endoscopic needle, single-use

• Primary Device ID: 08809327352432
• NIH Device Record Key: 96e22a0a-4a4a-4a5d-8978-7c489f3a2516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear-Jet Injection Catheter
• Version Model Number: FM-EI0004(2300)(0.1T)
• 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	08809327352432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181690

FDA Product Code

• FBK: Endoscopic Injection Needle, 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: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [Clear-Jet Injection Catheter ]

• 08809327352432: 23G-6mm/ 0.1T/ 2,300mm
• 18809327352422: 23G-4mm/ 0.08T/ 2,300mm/ Non-head
• 18809327352415: 23G-4mm/ 0.1T/ 1,800mm
• 18809327352408: 23G-4mm/ 0.05T/ 1,800mm
• 18809327352392: 23G-4mm/ 0.1T/ 2,300mm
• 18809327352385: 23G-4mm/ 0.05T/ 2,300mm
• 08809327351084: 23G-6mm/ 0.05T/ 2,300mm
• 18809327350671: 23G-4mm/ 0.05T/ 2,300mm/ Non-head
• 18809327350664: 23G-4mm/ 0.1T/ 2,300mm/ Non-head