FDA.reportPublic FDA data

PROACT Metal Max 50

Primary DI
35060179638028
Brand
PROACT Metal Max 50
Company
PROACT MEDICAL LIMITED
Model
MMCB50MAC0
Catalog number
MMCB50MAC0
Device description
Metal Max+ Combi 50 Laryngoscope with Batteries, Paediatric Macintosh 0
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
35060179638028PackageGS15In Commercial Distribution
25060179638021PrimaryGS10
15060179638024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506017963802835060179638028
2506017963802125060179638021
1506017963802415060179638024

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441536461981sales@proactmedical.co.uk

Regulatory Flags#

DUNS number
491090502
Device count
10
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
35056094500809PROACT Metal Max 100MMGS100MAC5MMGS100MAC52023-08-16
35056094501660PROACT Metal Max 90MMCV90PHI1MMCV90PHI12023-08-16
35056094500014PROACT Metal Max 90MMCB90MAC1MMCB90MAC12023-08-15
35056094500021PROACT Metal Max 90MMCB90MAC2MMCB90MAC22023-08-15
35056094500038PROACT Metal Max 90MMCB90MAC3MMCB90MAC32023-08-15
35056094500045PROACT Metal Max 90MMCB90MAC4MMCB90MAC42023-08-15
35056094500052PROACT Metal Max 90MMCB90MIL00MMCB90MIL002023-08-15
35056094500069PROACT Metal Max 90MMCB90MIL0MMCB90MIL02023-08-15
35056094500076PROACT Metal Max 90MMCB90MIL1MMCB90MIL12023-08-15
35056094500090PROACT Metal Max 90MMCB90LT3MMCB90LT32023-08-15
35056094500106PROACT Metal Max 90MMCB90LT4MMCB90LT42023-08-15
35056094500113PROACT Metal Max 90MMCV90MAC1MMCV90MAC12023-08-15
35056094500120PROACT Metal Max 90MMCV90MAC2MMCV90MAC22023-08-15
35056094500137PROACT Metal Max 90MMCV90MAC3MMCV90MAC32023-08-15
35056094500144PROACT Metal Max 90MMCV90MAC4MMCV90MAC42023-08-15
35056094500151PROACT Metal Max 90MMGS100CP0MMCV90MIL002023-08-15
35056094500168PROACT Metal Max 90MMCV90MIL0MMCV90MIL02023-08-15
35056094500175PROACT Metal Max 90MMCV90MIL1MMCV90MIL12023-08-15
35056094500182PROACT Metal Max 90MMCV90MIL2MMCV90MIL22023-08-15
35056094500199PROACT Metal Max 90MMCV90LT2MMCV90LT22023-08-15

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