FDA.report

PROACT MR Conditional

Primary DI
35060179635232
Brand
PROACT MR Conditional
Company
PROACT MEDICAL LIMITED
Model
MRHPCMIL1
Catalog number
MRHPCMIL1
Device description
MR Conditional HPC Green System Laryngoscope Blade, MIL 1
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35060179635232PackageGS110In Commercial Distribution
25060179635235PrimaryGS10
15060179635238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3506017963523235060179635232
2506017963523525060179635235
1506017963523815060179635238

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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35056094500076PROACT Metal Max 90MMCB90MIL1MMCB90MIL12023-08-15
35056094500090PROACT Metal Max 90MMCB90LT3MMCB90LT32023-08-15
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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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