FDA.reportPublic FDA data

Disposable Fiber Optic Laryngoscope Handle

Primary DI
G272D81010
Brand
Disposable Fiber Optic Laryngoscope Handle
Company
Maco International
Model
D8101
Catalog number
D8101
Published
2024-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G272D81010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, single-useA clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the 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 single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152941683
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G27231150Laryngoscope Blade Set Mac 1,2,4 Miller 1,2,4 Medium Handle311531152024-01-16
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

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