EasyFinder Fixed Curve Diagnostic Catheter

GUDID 06952450952368

Shanghai Microport Ep Medtech Co., Ltd.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 06952450952368
• NIH Device Record Key: 6f953388-463a-43f4-aee5-c7ead121f9f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyFinder Fixed Curve Diagnostic Catheter
• Version Model Number: EPD5JG010
• Company DUNS: 542965535
• Company Name: Shanghai Microport Ep Medtech 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: true
• 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	06952450952368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210313

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

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: 2024-02-29
• Device Publish Date: 2024-02-21

On-Brand Devices [EasyFinder Fixed Curve Diagnostic Catheter]

• 06952450942550: EPD6DD252
• 06952450952498: EPD6DC282
• 06952450952481: EPD6PC282
• 06952450952474: EPD5PC282
• 06952450952467: EPD6FB010
• 06952450952450: EPD6FB005
• 06952450952443: EPD6FB252
• 06952450952436: EPD6AB010
• 06952450952429: EPD6DB005
• 06952450952412: EPD6DB252
• 06952450952405: EPD6AB010
• 06952450952399: EPD6AB005
• 06952450952382: EPD6AB252
• 06952450952375: EPD6JG010
• 06952450952368: EPD5JG010
• 06952450952351: EPD6CG010
• 06952450952344: EPD5CG010
• 06952450952337: EPD6PE282
• 06952450952320: EPD6PE282
• 06952450952313: EPD5PE282
• 06952450952306: EPD6FD010
• 06952450952290: EPD6FD005
• 06952450952283: EPD6FD252
• 06952450952276: EPD6DD010
• 06952450952269: EPD6DD005
• 06952450952252: EPD6DD252
• 06952450952245: EPD6AD010
• 06952450952238: EPD6AD005
• 06952450952221: EPD6AD252
• 06952450942635: EPD6DE282
• 06952450942628: EPD6PE282
• 06952450942611: EPD5PE282
• 06952450942598: EPD6FD005
• 06952450919019: EPD6DC282
• 06952450919002: EPD6PC282
• 06952450918999: EPD5PC282