NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter R-410-152

GUDID B227NRP3680

NORTH EAST SCIENTIFIC INC

Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: B227NRP3680
• NIH Device Record Key: ca8a4fac-117b-4b8e-ba10-8f66022f0d2b
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter
• Version Model Number: R-410-152
• Catalog Number: R-410-152
• Company DUNS: 608625823
• Company Name: NORTH EAST SCIENTIFIC INC
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com
• Phone: 203-756-2111
• Email: matt@smarthealth-care.com

Device Dimensions

• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French
• Catheter Working Length: 150 Centimeter
• Lumen/Inner Diameter: 0.014 Inch
• Guidewire Compatibility: 4 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B227NRP3680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220171

FDA Product Code

• QTF: Reprocessed Atherectomy 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: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter]

• NRP368: The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed
• B227NRP3680: R-410-152
• 00850044399055: R-410-152