Disposable Endoscope Injection Needle MMIN-19-5

GUDID 06936603226544

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Flexible endoscopic biopsy handpiece/needle

• Primary Device ID: 06936603226544
• NIH Device Record Key: d66747f5-7b33-4eda-b1f3-05d94e3fa255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Endoscope Injection Needle
• Version Model Number: FTL-IN-24-230-19-5
• Catalog Number: MMIN-19-5
• Company DUNS: 544375774
• Company Name: Yangzhou Fartley Medical Instrument Technology 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936603226544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220292

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: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [Disposable Endoscope Injection Needle]

• 06936603226568: FTL-IN-24-230-23-5
• 06936603226551: FTL-IN-24-230-22-5
• 06936603226544: FTL-IN-24-230-19-5