NES Reprocessed Visions PV .018 Digital IVUS Catheter

Basic Information

• Brand Name: NES Reprocessed Visions PV .018 Digital IVUS Catheter
• Primary DI: 00850044399178
• Version / Model: R-86700
• Catalog Number: R-86700
• Company Name: NORTH EAST SCIENTIFIC INC
• Labeler DUNS: 608625823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-19
• Public Version: 1
• Public Version Date: 2025-05-27
• Public Version Status: New
• Public Device Record Key: 642d958d-868b-4ff3-bd3a-220c4bb1aa47

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	870.1200	2
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64174	Intravascular ultrasound imaging catheter, reprocessed	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850044399178	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250592	000

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	135	Centimeter
Lumen/Inner Diameter	0.018	Inch
Introducer Sheath Compatibility	6	French