FDA.reportPublic FDA data

PROACT MR Conditional

Primary DI
25060179635167
Brand
PROACT MR Conditional
Company
PROACT MEDICAL LIMITED
Model
MRGSHB01
Catalog number
MRGSHB01
Device description
MR Conditional Metal Max+ Green System Laryngoscope Handle with Re-usable Batteries, Adult
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
35060179635164PackageGS110In Commercial Distribution
25060179635167PrimaryGS10
15060179635160Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506017963516435060179635164
2506017963516725060179635167
1506017963516015060179635160

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.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
491090502
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25056094500802PROACT Metal Max 100MMGS100MAC5MMGS100MAC52023-08-16
25056094501663PROACT Metal Max 90MMCV90PHI1MMCV90PHI12023-08-16
35056094500809PROACT Metal Max 100MMGS100MAC5MMGS100MAC52023-08-16
35056094501660PROACT Metal Max 90MMCV90PHI1MMCV90PHI12023-08-16
25056094500017PROACT Metal Max 90MMCB90MAC1MMCB90MAC12023-08-15
25056094500024PROACT Metal Max 90MMCB90MAC2MMCB90MAC22023-08-15
25056094500031PROACT Metal Max 90MMCB90MAC3MMCB90MAC32023-08-15
25056094500048PROACT Metal Max 90MMCB90MAC4MMCB90MAC42023-08-15
25056094500055PROACT Metal Max 90MMCB90MIL00MMCB90MIL002023-08-15
25056094500062PROACT Metal Max 90MMCB90MIL0MMCB90MIL02023-08-15
25056094500079PROACT Metal Max 90MMCB90MIL1MMCB90MIL12023-08-15
25056094500093PROACT Metal Max 90MMCB90LT3MMCB90LT32023-08-15
25056094500109PROACT Metal Max 90MMCB90LT4MMCB90LT42023-08-15
25056094500116PROACT Metal Max 90MMCV90MAC1MMCV90MAC12023-08-15
25056094500123PROACT Metal Max 90MMCV90MAC2MMCV90MAC22023-08-15
25056094500130PROACT Metal Max 90MMCV90MAC3MMCV90MAC32023-08-15
25056094500147PROACT Metal Max 90MMCV90MAC4MMCV90MAC42023-08-15
25056094500154PROACT Metal Max 90MMGS100CP0MMCV90MIL002023-08-15
25056094500161PROACT Metal Max 90MMCV90MIL0MMCV90MIL02023-08-15
25056094500178PROACT Metal Max 90MMCV90MIL1MMCV90MIL12023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
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08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
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G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03