FDA.reportPublic FDA data

Technical Products

Primary DI
B051EZ1138
Brand
Technical Products
Company
TECHNICAL PRODUCTS INC
Model
EZ-1138
Catalog number
EZ-1138
Device description
SPEAK EZ
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B051EZ1138PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040679649
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B051EZ0813Technical ProductsEZ-0813EZ-08132024-02-16
B051EZ0815Technical ProductsEZ-0815EZ-08152024-02-16
B051EZ0817Technical ProductsEZ-0817EZ-08172024-02-16
B051EZ0819Technical ProductsEZ-0819EZ-08192024-02-16
B051EZ0821Technical ProductsEZ-0821EZ-08212024-02-16
B051EZ0823Technical ProductsEZ-0823EZ-08232024-02-16
B051EZ1111Technical ProductsEZ-1111EZ-11112024-02-16
B051EZ1113Technical ProductsEZ-1113EZ-11132024-02-16
B051EZ1115Technical ProductsEZ-1115EZ-11152024-02-16
B051EZ1119Technical ProductsEZ-1119EZ-11192024-02-16
B051EZ1122Technical ProductsEZ-1122EZ-11222024-02-16
B051EZ1124Technical ProductsEZ-1124EZ-11242024-02-16
B051EZ1127Technical ProductsEZ-1127EZ-11272024-02-16
B051EZ1130Technical ProductsEZ-1130EZ-11302024-02-16
B051EZ1135Technical ProductsEZ-1135EZ-11352024-02-16
B051EZ1311Technical ProductsEZ-1311EZ-13112024-02-16
B051EZ1313Technical ProductsEZ-1313EZ-13132024-02-16
B051EZ1315Technical ProductsEZ-1315EZ-13152024-02-16
B051EZ1319Technical ProductsEZ-1319EZ-13192024-02-16
B051EZ1322Technical ProductsEZ-1322EZ-13222024-02-16

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Primary DI, Brand, Company table
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