FDA.reportPublic FDA data

OSSEOUS

Primary DI
08904428722297
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E7182-OC
Device description
Standard Nasal Dressings sponges are designed to be placed inside the nasal cavities for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and allowing smooth septum ventilation to ensure patient comfort. The device in invasive with respect to body orifice.
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMXBalloon, Epistaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904428746224PackageGS110In Commercial Distribution
08904428722297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428746224089044287462248904428746224
08904428722297089044287222978904428722297

GMDN Terms#

Term, Definition table
TermDefinition
Nasal mucosa dressing, non-antimicrobialA material (e.g., solution, spray, gel, oil, balm) intended to be applied to nasal mucosa for one or a variety of therapeutic applications such as providing a protective barrier, hydrating the mucosa, washing/removing excessive secretions, loosening nasal encrustations, and/or reducing mucosal irritation/inflammation/oedema from environmental exposures (e.g., pet allergens, pollen), infection, or postsurgical healing, or for snoring control. It is composed of one or a combination of compounds (e.g., acids, provitamins, mannitol); it does not include an antimicrobial agent(s). It is intended for use in the home or a clinical setting. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.5Centimeter
Length8Centimeter
Width2Centimeter

Storage And Handling#

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

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00821925034662Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
08904428722075OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722082OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722099OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722105OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722112OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722129OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722136OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722143OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722150OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722167OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722174OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722181OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722198OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722204OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722211OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722228OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722235OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722242OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722259OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722266OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722273OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722280OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722303OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722310OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722327OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722334OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722341OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722358OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722365OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11