Hermes NC PTA Balloon Dilatation Catheter 820-030150-090U

GUDID 06958481450071

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481450071
• NIH Device Record Key: 9dbdf629-1a31-4523-9a66-4463b9350ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermes NC PTA Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 820-030150-090U
• 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	06958481450071 [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]

• 06958481451566: rev 01
• 06958481451559: rev 01
• 06958481451542: rev 01
• 06958481451535: rev 01
• 06958481451528: rev 01
• 06958481451511: rev 01
• 06958481451504: rev 01
• 06958481451498: rev 01
• 06958481451481: rev 01
• 06958481451474: rev 01
• 06958481451467: rev 01
• 06958481451450: rev 01
• 06958481451443: rev 01
• 06958481451436: rev 01
• 06958481451429: rev 01
• 06958481451412: rev 01
• 06958481451405: rev 01
• 06958481451399: rev 01
• 06958481451382: rev 01
• 06958481451375: rev 01
• 06958481451368: rev 01
• 06958481451351: rev 01
• 06958481451344: rev 01
• 06958481451337: rev 01
• 06958481451320: rev 01
• 06958481451313: rev 01
• 06958481451306: rev 01
• 06958481451290: rev 01
• 06958481451283: rev 01
• 06958481451276: rev 01
• 06958481451269: rev 01
• 06958481451252: rev 01
• 06958481451245: rev 01
• 06958481451238: rev 01
• 06958481451221: rev 01
• 06958481451214: rev 01
• 06958481451207: rev 01
• 06958481451191: rev 01
• 06958481451184: rev 01
• 06958481451177: rev 01
• 06958481451160: rev 01
• 06958481451153: rev 01
• 06958481451146: rev 01
• 06958481451139: rev 01
• 06958481451122: rev 01
• 06958481451115: rev 01
• 06958481451108: rev 01
• 06958481451092: rev 01
• 06958481451085: rev 01
• 06958481451078: rev 01