FDA.report

OSSEOUS

Primary DI
08906039316773
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
EI1325160R
Device description
Suction tubes for Nose Reusable are used during Rhinology and evacuate liquid from nasal cavities.
Published
2024-06-21
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
false

Related Records

Product Codes

CodeName
KAMCannula, Sinus

Product Code Classifications

CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039316773PackageGS110In Commercial Distribution
08906039313697PrimaryGS10

GMDN Terms

TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Angle30degree
Length160Millimeter
Outer Diameter2.5Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true

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08904428799749OSSEOUS- Adhesion Remover PadEA910632026-03-13
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08906039318012OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461030892OSSEOUS- Shaver Blade Tube E2120-012026-03-13
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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

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