Single-Use Flexible Rhinolaryngoscope

Basic Information

• Brand Name: Single-Use Flexible Rhinolaryngoscope
• Primary DI: 06972197480481
• Version / Model: RL-E1E00
• Company Name: Hunan Vathin Medical Instrument Co., Ltd
• Labeler DUNS: 554484862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-17
• Public Version: 1
• Public Version Date: 2023-02-27
• Public Version Status: New
• Public Device Record Key: c4732bfb-83e4-4aac-bc11-39ce263e7222

Device Characteristics

• Single Use: Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63330	Flexible video otorhinolaryngoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972197480481	GS1

Premarket Submissions

Submission Number	Supplement Number
K221581	000