Capsule Extruder 2 60606596

GUDID D010606065960

Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules

Dentsply De Trey GmbH

Dental restorative material dispenser

• Primary Device ID: D010606065960
• NIH Device Record Key: 26f8325f-cd75-4a8a-96cb-fe2413accab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capsule Extruder 2
• Version Model Number: 60606596
• Catalog Number: 60606596
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• 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: true
• Serial Number: false
• 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: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter
• Length: 17.5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D010606065960 [Direct Marking]
HIBCC	D010606065961 [Primary]

FDA Product Code

• KXR: APPLICATOR, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-24
• Device Publish Date: 2020-12-16

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