Laryngostroboscope

Basic Information

• Brand Name: Laryngostroboscope
• Primary DI: 00848657070218
• Version / Model: 8000-S
• Catalog Number: 8000-S
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Labeler DUNS: 839138955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-12
• Public Version: 1
• Public Version Date: 2023-10-20
• Public Version Status: New
• Public Device Record Key: 1914e729-3e17-4586-980f-03f899718e01

Device Description

Laryngostroboscopes employ the oscillating light of a high-power fluorescent light source that is monitored by the laryngeal vibrations through a throat microphone.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQL	Laryngostroboscope	Ear, Nose, Throat	874.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848657070218	GS1

Customer Contacts

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