Teleport XT Microcatheter

GUDID 06934955915987

Catheter, Percutaneous

OrbusNeich Medical (ShenZhen) Co., Ltd.

Vascular microcatheter

• Primary Device ID: 06934955915987
• NIH Device Record Key: f332ec94-47af-4e5d-b553-e8bbd4883da4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teleport XT Microcatheter
• Version Model Number: 7321-150-01
• 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	06934955915987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231608

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2025-03-10
• Device Publish Date: 2025-03-01

On-Brand Devices [Teleport XT Microcatheter]

• 06934955916984: Catheter, Percutaneous
• 06934955916977: Catheter, Percutaneous
• 06934955916960: Catheter, Percutaneous
• 06934955915987: Catheter, Percutaneous
• 06934955915970: Catheter, Percutaneous
• 06934955915963: Catheter, Percutaneous