PathBuilder Transseptal Guiding Introducer

GUDID 06952450957004

Shanghai Microport Ep Medtech Co., Ltd.

Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set

• Primary Device ID: 06952450957004
• NIH Device Record Key: 76840884-aa31-4ab2-bbf7-898f09bade55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathBuilder Transseptal Guiding Introducer
• Version Model Number: TSL3638
• 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	06952450957004 [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: 2024-03-05
• Device Publish Date: 2024-02-26

On-Brand Devices [PathBuilder Transseptal Guiding Introducer]

• 06952450957202: TSR38185
• 06952450957196: TSR28185
• 06952450957189: TSR4818
• 06952450957172: TSR3818
• 06952450957165: TSR2818
• 06952450957158: TSR46385
• 06952450957141: TSR36385
• 06952450957134: TSR4638
• 06952450957127: TSR4638
• 06952450957110: TSR3638
• 06952450957103: TSR2638
• 06952450957097: TSL38185
• 06952450957080: TSL4818
• 06952450957073: TSL4818
• 06952450957066: TSL3818
• 06952450957059: TSL2818
• 06952450957042: TSL46385
• 06952450957035: TSL36385
• 06952450957028: TSL26385
• 06952450957011: TSL4638
• 06952450957004: TSL3638
• 06952450956991: TSL2638
• 06952450956984: TSR18185
• 06952450956977: TSR08185
• 06952450956960: TSR0818
• 06952450956953: TSR0818
• 06952450956946: TSR16385
• 06952450956939: TSR06385
• 06952450956922: TSR1638
• 06952450956915: TSR0638
• 06952450956908: TSL18185
• 06952450956892: TSL08185
• 06952450956885: TSL1818
• 06952450956878: TSL0818
• 06952450948149: TSL16385
• 06952450948132: TSL48185
• 06952450948125: TSL48185
• 06952450948118: TSL48185
• 06952450948101: TSL163 8