Atropos PTA Balloon Dilatation Catheter 819-040040-090U

GUDID 06958481447125

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481447125
• NIH Device Record Key: f8b77779-7c86-48c4-a560-b37c47b0f93a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atropos PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 819-040040-090U
• 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	06958481447125 [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: 2016-11-28

On-Brand Devices [Atropos PTA Balloon Dilatation Catheter]

• 06958481448726: rev 01
• 06958481448719: rev 01
• 06958481448702: rev 01
• 06958481448696: rev 01
• 06958481448689: rev 01
• 06958481448672: rev 01
• 06958481448665: rev 01
• 06958481448658: rev 01
• 06958481448641: rev 01
• 06958481448634: rev 01
• 06958481448627: rev 01
• 06958481448610: rev 01
• 06958481448603: rev 01
• 06958481448597: rev 01
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• 06958481448566: rev 01
• 06958481448559: rev 01
• 06958481448542: rev 01
• 06958481448535: rev 01
• 06958481448528: rev 01
• 06958481448511: rev 01
• 06958481448504: rev 01
• 06958481448498: rev 01
• 06958481448481: rev 01
• 06958481448474: rev 01
• 06958481448467: rev 01
• 06958481448450: rev 01
• 06958481448443: rev 01
• 06958481448436: rev 01
• 06958481448429: rev 01
• 06958481448412: rev 01
• 06958481448405: rev 01
• 06958481448399: rev 01
• 06958481448382: rev 01
• 06958481448375: rev 01
• 06958481448368: rev 01
• 06958481448351: rev 01
• 06958481448344: rev 01
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• 06958481448320: rev 01
• 06958481448313: rev 01
• 06958481448306: rev 01
• 06958481448290: rev 01
• 06958481448283: rev 01
• 06958481448276: rev 01
• 06958481448269: rev 01
• 06958481448252: rev 01
• 06958481448245: rev 01
• 06958481448238: rev 01