FDA.report

OSSEOUS- Shaver Blade Tube

Primary DI
08904461030892
Brand
OSSEOUS- Shaver Blade Tube
Company
EON MEDITECH PRIVATE LIMITED
Model
E2120-01
Device description
The Shaver Blade tube is to be used with dispensing liquid coolants in ENT surgery & Implant ology. It is used to make the saline solution flow and cool down the heat around the surgical operation area.
Published
2026-03-13
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
EQJBur, Ear, Nose And Throat

Product Code Classifications

CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904461030892PackageGS11In Commercial Distribution
08904461028783PrimaryGS10

GMDN Terms

TermDefinition
Tissue morcellation systemAn assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius0 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

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00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
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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
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
08904428747610OSSEOUS Blade-Curved Sinus Blades - N TypeEI22162024-07-10

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