Device
DISPOSABLE LED FIBER OPTIC LARYNGOSCOPE BLADE MACINTOSH SIZE 2
Manufacturer
KENTRON HEALTHCARE, INC.
Model: MC51002FO DI: 00810003755773 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-10 Current Version: 2026-05-18
Description
DISPOSABLE LED FIBER OPTIC LARYNGOSCOPE BLADE MACINTOSH SIZE 2
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 6529d1ff-eb88-44b6-a1a8-b58af4c89b1c
Distribution Status: In Commercial Distribution
DUNS Number: 618825723
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: BOX
Item #1 - Device ID: 10810003755770
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 20
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00810003755773
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00810003755773
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 46828
Name: Laryngoscope blade, single-use
Definition:
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 single-use device.
FDA Product Codes
CCW
Laryngoscope, Rigid