Polux PTA Balloon Dilatation Catheter 818-035150-070U

GUDID 06958481440591

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481440591
• NIH Device Record Key: 609ad4f4-01a6-4583-b38b-96158a50a796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polux PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 818-035150-070U
• 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	06958481440591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160256

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-31

On-Brand Devices [Polux PTA Balloon Dilatation Catheter]

• 06958481445602: rev 01
• 06958481445596: rev 01
• 06958481445589: rev 01
• 06958481445572: rev 01
• 06958481445565: rev 01
• 06958481445558: rev 01
• 06958481445541: rev 01
• 06958481445534: rev 01
• 06958481445527: rev 01
• 06958481445510: rev 01
• 06958481445503: rev 01
• 06958481445497: rev 01
• 06958481445480: rev 01
• 06958481445473: rev 01
• 06958481445466: rev 01
• 06958481445459: rev 01
• 06958481445442: rev 01
• 06958481445435: rev 01
• 06958481445428: rev 01
• 06958481445411: rev 01
• 06958481445404: rev 01
• 06958481445398: rev 01
• 06958481445381: rev 01
• 06958481445374: rev 01
• 06958481445367: rev 01
• 06958481445350: rev 01
• 06958481445343: rev 01
• 06958481445336: rev 01
• 06958481445329: rev 01
• 06958481445312: rev 01
• 06958481445305: rev 01
• 06958481445299: rev 01
• 06958481445282: rev 01
• 06958481445275: rev 01
• 06958481445268: rev 01
• 06958481445251: rev 01
• 06958481445244: rev 01
• 06958481445237: rev 01
• 06958481445220: rev 01
• 06958481445213: rev 01
• 06958481445206: rev 01
• 06958481445190: rev 01
• 06958481445183: rev 01
• 06958481445176: rev 01
• 06958481445169: rev 01
• 06958481445152: rev 01
• 06958481445145: rev 01
• 06958481445138: rev 01
• 06958481445121: rev 01
• 06958481445114: rev 01