Achilles NC PTA Balloon Dilatation Catheter 804-020015-090U

GUDID 06958481421026

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481421026
• NIH Device Record Key: c4722ed9-b0ed-4396-b185-099936326224
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Achilles NC PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 804-020015-090U
• 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	06958481421026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160941

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: 2017-06-30

On-Brand Devices [Achilles NC PTA Balloon Dilatation Catheter]

• 06958481422993: rev 01
• 06958481422986: rev 01
• 06958481422979: rev 01
• 06958481422962: rev 01
• 06958481422955: rev 01
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• 06958481422894: rev 01
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• 06958481422863: rev 01
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• 06958481422832: rev 01
• 06958481422825: rev 01
• 06958481422818: rev 01
• 06958481422801: rev 01
• 06958481422795: rev 01
• 06958481422788: rev 01
• 06958481422771: rev 01
• 06958481422764: rev 01
• 06958481422757: rev 01
• 06958481422740: rev 01
• 06958481422733: rev 01
• 06958481422726: rev 01
• 06958481422719: rev 01
• 06958481422702: rev 01
• 06958481422696: rev 01
• 06958481422689: rev 01
• 06958481422672: rev 01
• 06958481422665: rev 01
• 06958481422658: rev 01
• 06958481422641: rev 01
• 06958481422634: rev 01
• 06958481422627: rev 01
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• 06958481422580: rev 01
• 06958481422573: rev 01
• 06958481422566: rev 01
• 06958481422559: rev 01
• 06958481422542: rev 01
• 06958481422535: rev 01
• 06958481422528: rev 01
• 06958481422511: rev 01
• 06958481422504: rev 01