PathBuilder Transseptal Guiding Introducer

GUDID 06952450957127

Shanghai Microport Ep Medtech Co., Ltd.

Cardiac transseptal access set

• Primary Device ID: 06952450957127
• NIH Device Record Key: c5eb571f-e128-4b90-ad17-221717f79dd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathBuilder Transseptal Guiding Introducer
• Version Model Number: TSR4638
• 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	06952450957127 [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