NES Reprocessed Visions PV .018 Digital IVUS Catheter R-86700

GUDID 00850044399178

86700 Visions PV .018 Digital IVUS Catheter Reprocessed by Northeast Scientific

NORTH EAST SCIENTIFIC INC

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 00850044399178
• NIH Device Record Key: 642d958d-868b-4ff3-bd3a-220c4bb1aa47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed Visions PV .018 Digital IVUS Catheter
• Version Model Number: R-86700
• Catalog Number: R-86700
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com
• Phone: 2037562111
• Email: sales@nescientific.com

Device Dimensions

• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French
• Catheter Working Length: 135 Centimeter
• Lumen/Inner Diameter: 0.018 Inch
• Introducer Sheath Compatibilit: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044399178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250592

FDA Product Code

• OWQ: Reprocessed Intravascular Ultrasound 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: 2025-05-27
• Device Publish Date: 2025-05-19

Devices Manufactured by NORTH EAST SCIENTIFIC INC

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• 00850044399017 - NES Reprocessed Varicose Vein RF Catheter: 2025-05-29 The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood
• 00850044399024 - NES Reprocessed Varicose Vein RF Catheter: 2025-05-29 The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is intended for endovascular coagulation of blood
• 00850044399031 - NES Reprocessed RF Stylet (RFS): 2025-05-29
• 00850044399048 - EsoSure: 2025-05-29 The EsoSure Esophageal Retractor is intended to move the esophagus.
• 00850044399055 - NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter: 2025-05-29
• 00850044399062 - NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter: 2025-05-29 The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NE
• 00850044399079 - NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter: 2025-05-29