Device
DISPOSABLE LED FIBER OPTIC LARYNGOSCOPE BLADE MACINTOSH SIZE 2
Manufacturer
KENTRON HEALTHCARE, INC.
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