EasyFinder Fixed Curve Diagnostic catheter

GUDID 06952450942543

Shanghai Microport Ep Medtech Co., Ltd.

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• Primary Device ID: 06952450942543
• NIH Device Record Key: 69859277-7fd2-4732-886f-6a74adfd9f59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyFinder Fixed Curve Diagnostic catheter
• Version Model Number: EPD6AD010
• 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	06952450942543 [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: 2024-01-24
• Device Publish Date: 2024-01-16

On-Brand Devices [ EasyFinder Fixed Curve Diagnostic catheter]

• 06952450942543: EPD6AD010
• 06952450942536: EPD6AD005
• 06952450942529: EPD6AD252
• 06952450942659: EPD5CG010
• 06952450942574: EPD6DD010
• 06952450942567: EPD6DD005
• 06952450942710: EPD6JG010
• 06952450942697: EPD5JG010
• 06952450942673: EPD6CG010
• 06952450918982: EPD6FB010
• 06952450918975: EPD6FB005
• 06952450918968: EPD6FB252
• 06952450918951: EPD6DB010
• 06952450918944: EPD6DB005
• 06952450918937: EPD6DB252
• 06952450918920: EPD6AB010
• 06952450918913: EPD6AB005
• 06952450918906: EPD6AB252