FDA.report

OSSEOUS

Primary DI
08904428748013
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E3131430
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
08904428748013PackageGS11In Commercial Distribution
08904428723812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904428748013089044287480138904428748013
08904428723812089044287238128904428723812

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
Length30Millimeter
Outer Diameter19Millimeter

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

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