FDA.reportPublic FDA data

OSSEOUS

Primary DI
08904428746040
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E7189-O
Device description
Anatomical 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.
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
08904428746040PackageGS110In Commercial Distribution
08904428722112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428746040089044287460408904428746040
08904428722112089044287221128904428722112

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
Width3Centimeter

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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10855364004112Rhino-Pak 45mmMAR-MED INC.EMX2025-02-06
00855364004122Rhino-Pak 55mmMAR-MED INC.EMX2025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.EMX2025-02-06
00821925030831Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925022379Gyrus ACMIGyrus Acmi, Inc.EMX2024-07-25
30886158012222Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012239Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012246Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012253Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012260Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012284Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012291Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012314Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012321Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012338Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012345Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012352Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012369Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012376Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012383Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012390Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012406Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012437Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012444Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012451Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013243Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013267Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013274Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013281Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013298Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27