Teleport Microcatheter

GUDID 06934955943089

Caatheter, Percutaneous

OrbusNeich Medical (ShenZhen) Co., Ltd.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 06934955943089
• NIH Device Record Key: eb35b203-5403-43d7-a543-4a52baa20c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teleport Microcatheter
• Version Model Number: 221-15-1000U
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com

Device Dimensions

• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French
• Length: 150 Centimeter
• Catheter Gauge: 2.1 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955943089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182360

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: 2019-03-21
• Device Publish Date: 2018-11-28

On-Brand Devices [Teleport Microcatheter]

• 06934955943089: Caatheter, Percutaneous
• 06934955943072: Caatheter, Percutaneous
• 06934955943065: Caatheter, Percutaneous
• 06934955943058: Caatheter, Percutaneous