COREPASS Modular Microcatheter

GUDID 06934955934735

OrbusNeich Medical (ShenZhen) Co., Ltd.

Vascular microcatheter

• Primary Device ID: 06934955934735
• NIH Device Record Key: bd62fba3-40f6-4b1b-b08c-1123cb09a301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COREPASS Modular Microcatheter
• Version Model Number: 8425-135-02
• Company DUNS: 530923226
• Company Name: OrbusNeich Medical (ShenZhen) 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: false
• Manufacturing Date: true
• 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	06934955934735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242588

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-19
• Device Publish Date: 2025-03-01

On-Brand Devices [COREPASS Modular Microcatheter]

• 06934955934711: 8422-135-02
• 06934955934735: 8425-135-02
• 06934955934728: 8422-150-02
• 06934955934742: 8425-150-02