Carnegie Surgical LLC

Basic Information

• Brand Name: Carnegie Surgical LLC
• Primary DI: G1414045200
• Version / Model: 404-520
• Catalog Number: 404-520
• Company Name: Carnegie Surgical LLC
• Labeler DUNS: 017636482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-26
• Public Version: 1
• Public Version Date: 2023-04-03
• Public Version Status: New
• Public Device Record Key: a905850a-e5db-4c75-9871-422948f28f8a

Device Description

Laryngoscope conventional reusable handle, medium (requires 2C batteries, not included), chrome plated

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: 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
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46830	Laryngoscope handle, reusable	The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may 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	G1414045200	HIBCC

Customer Contacts

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