Parafleet SC 018 PTA Balloon Dilatation Catheter F18-060080-200

GUDID 06942265515582

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06942265515582
• NIH Device Record Key: cc695fbd-e4ee-444e-ab95-4dfcee656817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parafleet SC 018 PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: F18-060080-200
• Company DUNS: 421318800
• Company Name: BrosMed Medical 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942265515582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243704

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [Parafleet SC 018 PTA Balloon Dilatation Catheter]

• 06942265515940: rev 01
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• 06942265508331: rev 01