OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type

GUDID 08904461000536

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 ID: 08904461000536
• NIH Device Record Key: f4765641-782d-4a09-a25e-58fbc6c0b6fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type
• Version Model Number: EI2204
• 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

• Outer Diameter: 4 Millimeter
• Angle: 40 degree
• Outer Diameter: 4 Millimeter
• Angle: 40 degree
• Outer Diameter: 4 Millimeter
• Angle: 40 degree
• Outer Diameter: 4 Millimeter
• Angle: 40 degree
• Outer Diameter: 4 Millimeter
• Angle: 40 degree

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904461000529 [Primary]
GS1	08904461000536 [Package]; Contains: 08904461000529; Package: Laminated Box [1 Units]; In Commercial Distribution

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: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type]

• 08904461000536: ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use w
• 08904428747528: ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use w
• 08904428747535: ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use w