Tiche PTA Balloon Dilatation Catheter 34-080813

GUDID 06958481477559

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06958481477559
• NIH Device Record Key: 6e9d85f9-e423-4e83-8ae9-b6f5cb35db98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tiche PTA Balloon Dilatation Catheter
• Version Model Number: rev01
• Catalog Number: 34-080813
• 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	06958481477559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212215

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-15
• Device Publish Date: 2023-05-06

On-Brand Devices [Tiche PTA Balloon Dilatation Catheter]

• 06958481475074: rev 01
• 06958481475067: rev 01
• 06958481475050: rev 01
• 06958481475043: rev 01
• 06958481475036: rev 01
• 06958481475029: rev 01
• 06958481475012: rev 01
• 06958481476002: rev01
• 06958481475203: rev01
• 06958481475197: rev01
• 06958481475180: rev01
• 06958481475173: rev01
• 06958481475166: rev01
• 06958481475159: rev01
• 06958481475142: rev01
• 06958481475135: rev01
• 06958481475128: rev01
• 06958481475111: rev01
• 06958481475104: rev01
• 06958481475098: rev01
• 06958481475081: rev01
• 06958481477788: rev01
• 06958481477771: rev01
• 06958481477764: rev01
• 06958481477757: rev01
• 06958481477740: rev01
• 06958481477733: rev01
• 06958481477726: rev01
• 06958481477719: rev01
• 06958481477702: rev01
• 06958481477696: rev01
• 06958481477689: rev01
• 06958481477672: rev01
• 06958481477665: rev01
• 06958481477658: rev01
• 06958481477641: rev01
• 06958481477634: rev01
• 06958481477627: rev01
• 06958481477610: rev01
• 06958481477603: rev01
• 06958481477597: rev01
• 06958481477580: rev01
• 06958481477573: rev01
• 06958481477566: rev01
• 06958481477559: rev01
• 06958481477542: rev01
• 06958481477535: rev01
• 06958481477528: rev01
• 06958481477511: rev01
• 06958481477504: rev01