FDA.report

OSSEOUS

Primary DI
08906039314380
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E3131818
Device description
Laryngectomy Button is a self-retaining holder for device in the intended for vocal and pulmonary rehabilitation after Laryngectomy. It can supply stomal support and help to keep the tracheostoma open.
Published
2024-06-12
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

Related Records

Product Codes

CodeName
KACTube, Laryngectomy

Product Code Classifications

CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039314380PackageGS11In Commercial Distribution
08906039312089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906039314380089060393143808906039314380
08906039312089089060393120898906039312089

GMDN Terms

TermDefinition
Tracheostoma buttonA hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.

Device Sizes

TypeValueUnit
Length18Millimeter
Outer Diameter18Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

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 DIBrandModelCatalogPublished
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
08904428799749OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461030892OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055024OSSEOUS-SnorOFFE317012026-03-13
08904428798377OSSEOUS-CapsuleEA9100182026-03-13
08904428747672OSSEOUS Blade - Inferior turbinate - N TypeEI22222024-07-10
08904428747665OSSEOUS Blade - Inferior turbinate - N TypeEI22212024-07-10
08904428747658OSSEOUS Blade-Straight Sinus Blades - N TypeEI22202024-07-10
08904428747641OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22192024-07-10
08904428747634OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22182024-07-10
08904428747627OSSEOUS Blade-Curved Sinus Blades - TypeEI22172024-07-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
08904428748006OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428748013OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314533OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314519OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314496OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314465OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314441OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314427OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314403OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428750634OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750641OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750658OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750665OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750672OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750689OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750696OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750702OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039311716OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039315202OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039315165OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10