TN-Brush TN-1.0

GUDID 08809552960600

DENTAL SCALER, ROTARY

GENOSS CO., Ltd.

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• Primary Device ID: 08809552960600
• NIH Device Record Key: fd86b412-bda3-4797-b7b3-689ac44fccbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TN-Brush
• Version Model Number: TN-1.0
• Catalog Number: TN-1.0
• Company DUNS: 690083006
• Company Name: GENOSS CO., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter
• Length: 3.5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809552960600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170596

FDA Product Code

• ELB: SCALER, ROTARY

Sterilization

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

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

[08809552960600]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-07
• Device Publish Date: 2018-07-10

On-Brand Devices [TN-Brush]

• 08809552960600: DENTAL SCALER, ROTARY
• 08809552960594: DENTAL SCALER, ROTARY