FDA.reportPublic FDA data

Adjustable Reconstruction Tube

Primary DI
00815347023755
Brand
Adjustable Reconstruction Tube
Company
HOOD, E BENSON LABORATORIES INC
Model
ERT-14
Device description
Esophageal Prosthesis
Published
2017-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KACTube, Laryngectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815347023755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815347023755008153470237558153470237550815347023755

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
076603380
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815347020082Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1512-S2023-11-21
00815347020099Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1814-S2023-11-21
00815347023762Radiopaque Bronchial Stent with PostsRBSP1-1030-S2023-11-21
00815347023779Radiopaque Bronchial Stent with PostsRBSP1-1230-S2023-11-21
00815347023786Radiopaque Bronchial Stent with PostsRBSP1-1240-S2023-11-21
00815347023793Radiopaque Tracheal Stent with PostsRTSP-1450-S2023-11-21
00815347023809Radiopaque Tracheal Stent with PostsRTSP-1650-S2023-11-21
00815347023816Radiopaque Bronchial Stent with PostsRBSP1-1250-S2023-11-21
00815347024011Radiopaque Hour Glass Stent with PostsRHGS-1614-S2023-11-21
00815347024028Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1410-S2023-11-21
00815347024035Y-Stent with Tracheal Posts with 1mm Wall ThicknessYS1-1613-S2023-11-21
00815347020358Extra Long Tracheal T-TubeELT-06-S2015-10-27
00815347020365Long Tracheal T-TubeLT-506-S2015-10-27
00815347020372Long Tracheal T-TubeLT-507-S2015-10-27
00815347020389Extra Long Tracheal T-TubeELT-07-S2015-10-27
00815347020396Extra Long Tracheal T-TubeELT-08-S2015-10-27
00815347020402Long Tracheal T-TubeLT-508-S2015-10-27
00815347020419Extra Long Tracheal T-TubeELT-10-S2015-10-27
00815347020426Long Tracheal T-TubeLT-509-S2015-10-27
00815347020433Long Tracheal T-TubeLT-510-S2015-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428723706OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
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08904428723744OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
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08904428723775OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
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08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12