Flexible Video Rhino Laryngoscope

Basic Information

• Brand Name: Flexible Video Rhino Laryngoscope
• Primary DI: B809M205220310101
• Version / Model: RSX-P
• Catalog Number: M-205-22031-0101
• Company Name: orlvision GmbH
• Labeler DUNS: 341467978
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-06
• Public Version: 2
• Public Version Date: 2020-10-20
• Public Version Status: Update
• Public Device Record Key: 0ef6f68c-4ac5-4ea4-80c2-034ce9fdc8da
• Distribution End Date: 2020-10-19

Device Description

Flexible Video Rhino Laryngoscope, diameter flexible end 2,9 mm

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQN	Laryngoscope, Nasopharyngoscope	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45043	Flexible video nasopharyngoscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B809M205220310101	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K150248	000