Tri-Wedge PTA Scoring Balloon Dilatation Catheter 21-35E63

GUDID 06958481467642

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481467642
• NIH Device Record Key: 5ea5c942-3f15-4a97-947d-3115c662f9b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Wedge PTA Scoring Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 21-35E63
• 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	06958481467642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241478

FDA Product Code

• PNO: Catheter, Percutaneous, Cutting/Scoring

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Tri-Wedge PTA Scoring Balloon Dilatation Catheter]

• 06958481466522: rev 01
• 06958481466515: rev 01
• 06958481466508: rev 01
• 06958481466492: rev 01
• 06958481465969: rev 01
• 06958481465952: rev 01
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• 06958481465884: rev 01
• 06958481465877: rev 01
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• 06958481465853: rev 01
• 06958481465846: rev 01
• 06958481465839: rev 01
• 06958481465822: rev 01
• 06958481465815: rev 01
• 06958481465808: rev 01
• 06958481465792: rev 01
• 06958481465785: rev 01
• 06958481465778: rev 01
• 06958481465761: rev 01
• 06958481465754: rev 01
• 06958481465747: rev 01
• 06958481465730: rev 01
• 06958481465723: rev 01
• 06958481465716: rev 01
• 06958481465709: rev 01
• 06958481465693: rev 01
• 06958481465686: rev 01
• 06958481465679: rev 01
• 06958481465662: rev 01
• 06958481465655: rev 01
• 06958481465648: rev 01
• 06958481465631: rev 01
• 06958481465624: rev 01
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• 06958481465600: rev 01
• 06958481465594: rev 01
• 06958481465587: rev 01
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• 06958481465563: rev 01
• 06958481465556: rev 01
• 06958481465549: rev 01
• 06958481465532: rev 01
• 06958481465525: rev 01
• 06958481465518: rev 01