NvisionVLE Low Profile Imaging Probe, 20mm Working Distance

Basic Information

• Brand Name: NvisionVLE Low Profile Imaging Probe, 20mm Working Distance
• Primary DI: 00859591006201
• Version / Model: 95501-20
• Catalog Number: 95501-20
• Company Name: NINEPOINT MEDICAL, INC.
• Labeler DUNS: 961880999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 426e34e9-9203-456d-8962-5404a4398bc8

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: No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62327	Endoscopic optical coherence tomography system probe	A sterile endoscopic device intended to scan cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract] at a microscopic level. It is a flexible fibreoptic bundle with a rotating distal end designed to emit a light beam whereby real-time, in-depth, high-resolution imagery is produced by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It is inserted through the working channel of an endoscope and may be inflated in situ with an inflator; the proximal end connects to the system’s console. It may also be used ex-vivo. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859591006201	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143678	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.7	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -28 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity