FDA.reportPublic FDA data

OSSEOUS

Primary DI
08904428750634
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E31108LS
Device description
Laryngectomy Tube is designed to maintain an airway of Laryngectomy and also to maintain the opening of the tracheostoma.
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
08904428750634PackageGS11In Commercial Distribution
08904428752980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428750634089044287506348904428750634
08904428752980089044287529808904428752980

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tubeA hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55.01Millimeter
Lumen/Inner Diameter25.91Millimeter
Outer Diameter31.55Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
930270428
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428723706OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723713OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723720OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723737OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723744OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723751OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723768OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723775OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723782OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723799OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723805OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723812OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312010OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312027OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312034OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312041OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312058OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312065OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312072OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312089OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747900OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747917OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747924OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747931OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747948OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747955OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12