OSSEOUS Burs-Course Diamond

GUDID 08904461000857

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 ID: 08904461000857
• NIH Device Record Key: a337de0b-f226-4d05-824e-a306a8deeeff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS Burs-Course Diamond
• Version Model Number: EI2110CD
• Company DUNS: 930270428
• Company Name: EON MEDITECH PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter
• Length: 70 Millimeter
• Outer Diameter: 1 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904461000857 [Package]; Contains: 08904461000932; Package: Laminated Box [10 Units]; In Commercial Distribution
GS1	08904461000932 [Primary]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-12
• Device Publish Date: 2024-07-04

On-Brand Devices [OSSEOUS Burs-Course Diamond]

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