OSSEOUS Burs-Course Diamond

GUDID 08904461000871

Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT conditions and anatomies from precise excision in delicate areas to rapid removal of large and bulky lesions.

EON MEDITECH PRIVATE LIMITED

Diamond ENT bur, single-use
Primary Device ID08904461000871
NIH Device Record Key327b3bbc-e707-4e68-a810-e2f6b03b62c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS Burs-Course Diamond
Version Model NumberEI2140CD
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

Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter
Length70 Millimeter
Outer Diameter4 Millimeter

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
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
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
GS108904461000871 [Package]
Contains: 08904461000956
Package: Laminated Box [10 Units]
In Commercial Distribution
GS108904461000956 [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 Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [OSSEOUS Burs-Course Diamond]

08906039315677Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315691Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08904461000864Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08904461000857Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08904461000840Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315608Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315615Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315622Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315653Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08906039315660Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit
08904461000871Burs- Course Diamond are designed for giving the flexibility to treat a wide range of ENT condit

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