Minerva PTA Balloon Dilatation Catheter 803-035200-090U

GUDID 06958481415605

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481415605
• NIH Device Record Key: 137d5e88-101f-46ca-9b56-030486c21a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minerva PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 803-035200-090U
• 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	06958481415605 [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 [Minerva PTA Balloon Dilatation Catheter]

• 06958481419962: rev 01
• 06958481419955: rev 01
• 06958481419948: rev 01
• 06958481419931: rev 01
• 06958481419924: rev 01
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• 06958481419795: rev 01
• 06958481419788: rev 01
• 06958481419771: rev 01
• 06958481419764: rev 01
• 06958481419757: rev 01
• 06958481419740: rev 01
• 06958481419733: rev 01
• 06958481419726: rev 01
• 06958481419719: rev 01
• 06958481419702: rev 01
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• 06958481419665: rev 01
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• 06958481419641: rev 01
• 06958481419634: rev 01
• 06958481419627: rev 01
• 06958481419610: rev 01
• 06958481419603: rev 01
• 06958481419597: rev 01
• 06958481419580: rev 01
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• 06958481419559: rev 01
• 06958481419542: rev 01
• 06958481419535: rev 01
• 06958481419528: rev 01
• 06958481419511: rev 01
• 06958481419504: rev 01
• 06958481419498: rev 01
• 06958481419481: rev 01
• 06958481419474: rev 01