OSSEOUS Blades-Straight Sinus Blades - N Type

GUDID 08904461001564

ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system to remove tissue, bone, or other obstructions in the sinuses.

EON MEDITECH PRIVATE LIMITED

Nasal biopsy curette
Primary Device ID08904461001564
NIH Device Record Keyb1c2b159-cc1b-4433-949c-532bda36f018
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS Blades-Straight Sinus Blades - N Type
Version Model NumberEI2212
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

Device Dimensions

Outer Diameter4 Millimeter
Angle0 degree
Outer Diameter4 Millimeter
Angle0 degree
Outer Diameter4 Millimeter
Angle0 degree
Outer Diameter4 Millimeter
Angle0 degree
Outer Diameter4 Millimeter
Angle0 degree

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108904461001564 [Package]
Contains: 08904461001571
Package: Laminated Box [1 Units]
In Commercial Distribution
GS108904461001571 [Primary]

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 Date2024-07-18
Device Publish Date2024-07-10

Devices Manufactured by EON MEDITECH PRIVATE LIMITED

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08904428747665 - OSSEOUS Blade - Inferior turbinate - N Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
08904428747658 - OSSEOUS Blade-Straight Sinus Blades - N Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
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08904428747634 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
08904428747627 - OSSEOUS Blade-Curved Sinus Blades - Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
08904428747610 - OSSEOUS Blade-Curved Sinus Blades - N Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
08904428747603 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system
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