OSSEOUS- Shaver Blade Tube

GUDID 08904461030892

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.

EON MEDITECH PRIVATE LIMITED

Tissue morcellation system
Primary Device ID08904461030892
NIH Device Record Key0cb2586f-16d4-4add-ac92-e6ec01703d67
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS- Shaver Blade Tube
Version Model NumberE2120-01
Company DUNS930270428
Company NameEON MEDITECH PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108904461028783 [Primary]
GS108904461030892 [Package]
Contains: 08904461028783
Package: Laminated Box [1 Units]
In Commercial Distribution

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-23
Device Publish Date2026-03-13

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08904428798421 - OSSEOUS- ShowerProtect2026-03-23 Shower guard is used to temporarily replace the HME during showering.
08904428798438 - OSSEOUS- NeckFit Tube Holder2026-03-23 Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special des
08904428798483 - OSSEOUS- Tube Cleaning Brush - 8mm2026-03-23 The tube cleaning brush is used to clean Laryngectomy tube &Laryngectomy button
08904428798469 - OSSEOUS-Cleaning Pad2026-03-23
08904428799749 - OSSEOUS- Adhesion Remover Pad2026-03-23 The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and

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