Hermes NC PTA Balloon Dilatation Catheter 820-100020-070U

GUDID 06958481449501

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481449501
• NIH Device Record Key: f35b442a-c8c6-4736-9ebe-6721f240c433
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermes NC PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 820-100020-070U
• 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	06958481449501 [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 [Hermes NC PTA Balloon Dilatation Catheter]

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