FDA.reportPublic FDA data

PROACT Smoothline

Primary DI
35056094501523
Brand
PROACT Smoothline
Company
PROACT MEDICAL LIMITED
Model
H9029
Catalog number
H9029
Device description
Smoothline Green System Laryngoscope Blade, MIL 00
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
false

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
35056094501523PackageGS150In Commercial Distribution
25056094501526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3505609450152335056094501523
2505609450152625056094501526

GMDN Terms#

Term, Definition table
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.

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
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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

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