PathBuilder Transseptal Guiding Introducer

GUDID 06952450948095

Shanghai Microport Ep Medtech Co., Ltd.

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• Primary Device ID: 06952450948095
• NIH Device Record Key: 8372a84b-cd9a-4e0a-8543-97ecd509e75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathBuilder Transseptal Guiding Introducer
• Version Model Number: TSL0638
• 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	06952450948095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212626

FDA Product Code

• DYB: Introducer, Catheter

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: 2024-03-04
• Device Publish Date: 2024-02-23

Devices Manufactured by Shanghai Microport Ep Medtech Co., Ltd.

• 06952450948101 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450948118 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450948125 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450948132 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450948149 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450956878 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450956885 - PathBuilder Transseptal Guiding Introducer: 2024-03-05
• 06952450956892 - PathBuilder Transseptal Guiding Introducer: 2024-03-05