Teleport Microcatheter

GUDID 06934955943089

Caatheter, Percutaneous

OrbusNeich Medical (ShenZhen) Co., Ltd.

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