OSSEOUS Blade-Straight Sinus Blades - M Type

GUDID 08904428747542

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 ID08904428747542
NIH Device Record Key9a18a1d1-9153-405a-a85f-df69fa38db02
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS Blade-Straight Sinus Blades - M Type
Version Model NumberEI2209
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 Diameter2.9 Millimeter
Angle0 degree
Outer Diameter2.9 Millimeter
Angle0 degree
Outer Diameter2.9 Millimeter
Angle0 degree
Outer Diameter2.9 Millimeter
Angle0 degree
Outer Diameter2.9 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
GS108904428723539 [Primary]
GS108904428747542 [Package]
Contains: 08904428723539
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 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
08904428747641 - 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
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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