DUO-PEN 4007-2073

GUDID 08806383557016

Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)

DiaDent Group International

Endodontic obturation system

• Primary Device ID: 08806383557016
• NIH Device Record Key: cf387281-4eda-46cf-b219-0614a626f6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUO-PEN
• Version Model Number: DUO-PEN HEATING CONDENSOR(06-50)
• Catalog Number: 4007-2073
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383557016 [Primary]

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

Sterilization

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

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

[08806383557016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [DUO-PEN]

• 08806383557351: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557344: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557337: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557320: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557108: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557023: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557016: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383557009: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383556996: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383556989: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca
• 08806383586320: Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root ca