LITESCOPE™ LARYNGOSCOPE

Basic Information

• Brand Name: LITESCOPE™ LARYNGOSCOPE
• Primary DI: 05030267153114
• Version / Model: 7124000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: aaea1150-2934-4171-957f-6efa8ab8a4ae
• Distribution End Date: 2023-07-11

Device Description

LITESCOPE™ LARYNGOSCOPE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
62918	Rigid intubation laryngoscope, single-use	A hand-held disposable 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 are magnetic resonance imaging (MRI) compatible. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05030267153121	GS1		10	Not in Commercial Distribution	2023-07-11
Primary	05030267153114	GS1

Customer Contacts

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