POT PTCA Balloon Dilatation Catheter 833-3006

GUDID 06958481438758

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06958481438758
• NIH Device Record Key: 84cc7013-308d-4431-834b-9d1538d5c541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POT PTCA Balloon Dilatation Catheter
• Version Model Number: rev01
• Catalog Number: 833-3006
• 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	06958481438758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230705

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: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [POT PTCA Balloon Dilatation Catheter]

• 06958481438802: rev01
• 06958481438796: rev01
• 06958481438789: rev01
• 06958481438772: rev01
• 06958481438765: rev01
• 06958481438758: rev01
• 06958481438741: rev01
• 06958481438734: rev01
• 06958481438727: rev01
• 06958481438710: rev01
• 06958481438703: rev01
• 06958481438697: rev01
• 06958481438680: rev01
• 06958481438673: rev01
• 06958481438666: rev01
• 06958481438659: rev01
• 06958481438642: rev01
• 06958481438635: rev01
• 06958481438628: rev01
• 06958481438611: rev01
• 06958481438604: rev01
• 06958481438598: rev01
• 06958481438581: rev01
• 06958481438574: rev01
• 06958481438567: rev01
• 06958481438550: rev01
• 06958481438543: rev01
• 06958481438536: rev01
• 06958481438529: rev01
• 06958481438512: rev01
• 06958481438505: rev01
• 06958481438499: rev01
• 06958481438482: rev01
• 06958481438475: rev01
• 06958481438468: rev01
• 06958481438451: rev01
• 06958481438444: rev01
• 06958481438437: rev01
• 06958481438420: rev01
• 06958481438413: rev01
• 06958481438406: rev01
• 06958481438390: rev01
• 06958481438383: rev01
• 06958481438376: rev01
• 06958481438369: rev01
• 06958481438352: rev01
• 06958481438345: rev01
• 06958481438338: rev01
• 06958481438321: rev01