FDA.reportPublic FDA data

Laryngoscope Blade Set Mac 1,2,4 Miller 1,2,4 Medium Handle

Primary DI
G27231150
Brand
Laryngoscope Blade Set Mac 1,2,4 Miller 1,2,4 Medium Handle
Company
Maco International
Model
3115
Catalog number
3115
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G27231150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
152941683
Device count
1
Premarket exempt
true
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G27260400Disposable Conventional Laryngoscope Blade604060402024-01-16
G27260410Disposable Conventional Laryngoscope Blade604160412024-01-16
G27260420Disposable Conventional Laryngoscope Blade604260422024-01-16
G27260430Disposable Conventional Laryngoscope Blade604360432024-01-16
G27260440Disposable Conventional Laryngoscope Blade604460442024-01-16
G27270600Disposable Conventional Laryngoscope Blade706070602024-01-16
G27270610Disposable Conventional Laryngoscope Blade706170612024-01-16
G27270620Disposable Conventional Laryngoscope Blade706270622024-01-16
G27270630Disposable Conventional Laryngoscope Blade706370632024-01-16
G272706350Disposable Conventional Laryngoscope Blade7063.57063.52024-01-16
G27270640Disposable Conventional Laryngoscope Blade706470642024-01-16
G27273340Magill Forcep Infant733473342024-01-16
G27273370Magill Forcep Child733773372024-01-16
G27273380Magill Forcep Adult733873382024-01-16
G27278600Conventional Laryngoscope Handle786078602024-01-16
G27278620Conventional Laryngoscope Handle786278622024-01-16
G27279610Conventional Laryngoscope Handle796179612024-01-16
G272822500Phillips Blade8225-08225-02024-01-16
G272822510Phillips Blade8225-18225-12024-01-16
G272866200Wisconsin Blade8662-08662-02024-01-16