CanalPro

GUDID D661600235260

Endo-Ice Green

COLTENE/WHALEDENT INC

Cryogenic spray, dental

• Primary Device ID: D661600235260
• NIH Device Record Key: 1bdac88b-efec-4478-b4af-cd613fdd3db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CanalPro
• Version Model Number: 60023526
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3309168800
• Email: info.us@coltene.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D661600235260 [Primary]

FDA Product Code

• EAT: Tester, Pulp

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: 2020-01-08
• Device Publish Date: 2019-12-31

On-Brand Devices [CanalPro]

• D661600235260: Endo-Ice Green
• D661600111780: CanalPro Syringe Station
• 10840016202053: Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black pr