FDA.report

Macintosh FO German Blade

Primary DI
G272FO23120
Brand
Macintosh FO German Blade
Company
Maco International
Model
FO2312
Catalog number
FO2312
Published
2024-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G272FO23120PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
152941683
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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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