FDA.report

BriteBlade Pro Single-Use Fiber Optic Miller 0

Primary DI
05055788709121
Brand
BriteBlade Pro Single-Use Fiber Optic Miller 0
Company
FLEXICARE MEDICAL LIMITED
Model
040-717U
Device description
BriteBlade Pro Single-Use Fiber Optic Miller 0
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788709121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788709121050557887091215055788709121

GMDN Terms

TermDefinition
Laryngoscope blade, single-useThe 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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