JEDMED

Basic Information

• Brand Name: JEDMED
• Primary DI: M63349X40740
• Version / Model: 49X4074
• Catalog Number: 49X4074
• Company Name: JEDMED INSTRUMENT COMPANY
• Labeler DUNS: 092987189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 69a04e7e-63c9-4016-b12e-9605a8fc2d8e

Device Description

RIGID LARYNG W/O LT CBL 70-DEG 10MM

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: No
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: High-level Disinfectant

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
43946	Rigid optical laryngopharyngoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M63349X40740	HIBCC