SunMed

Basic Information

• Brand Name: SunMed
• Primary DI: 10889483166208
• Version / Model: 5-5273-47
• Catalog Number: 5-5273-47
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-25
• Public Version: 1
• Public Version Date: 2023-08-02
• Public Version Status: New
• Public Device Record Key: cac62862-881f-4ecd-af78-7b4f21206ee0

Device Description

F/O G-MIL 0 1 2 3 4 w/SunBrite LED Handle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	LARYNGOSCOPE, RIGID	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46827	Laryngoscope blade, reusable	The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are 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	10889483166208	GS1

Customer Contacts

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