Catheters, transluminal coronary angioplasty,percutaneous 801-1025U

GUDID 06958481412604

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06958481412604
• NIH Device Record Key: 463a0a86-f392-4285-9686-9dcddea9170a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catheters, transluminal coronary angioplasty,percutaneous
• Version Model Number: rev 01
• Catalog Number: 801-1025U
• 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	06958481412604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203390

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

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: 2021-09-10
• Device Publish Date: 2021-09-02

On-Brand Devices [Catheters, transluminal coronary angioplasty,percutaneous]

• 06958481412666: rev 01
• 06958481412659: rev 01
• 06958481412642: rev 01
• 06958481412635: rev 01
• 06958481412628: rev 01
• 06958481412611: rev 01
• 06958481412604: rev 01
• 06958481412598: rev 01
• 06958481412581: rev 01
• 06958481412574: rev 01
• 06958481412567: rev 01
• 06958481412550: rev 01
• 06958481412543: rev 01
• 06958481412536: rev 01
• 06958481412529: rev 01
• 06958481412512: rev 01