Carnegie Surgical LLC

Basic Information

• Brand Name: Carnegie Surgical LLC
• Primary DI: G14140466280
• Version / Model: 404-6628
• Catalog Number: 404-6628
• Company Name: Carnegie Surgical LLC
• Labeler DUNS: 017636482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-03
• Public Version: 1
• Public Version Date: 2023-04-11
• Public Version Status: New
• Public Device Record Key: f8362def-28d9-4a4e-a17b-1f3612c7260e

Device Description

MACINTOSH Laryngoscope blade fig 2, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (93 mm) (pack of 10)

Device Characteristics

• Single Use: Yes
• 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: 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	G14140466281	HIBCC	Box	10	In Commercial Distribution
Primary	G14140466280	HIBCC
Package	G14140466282	HIBCC	Carton	10	In Commercial Distribution

Customer Contacts

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