CCD BLUEWAVE LASER 444000L

GUDID D813444000L0

CCD LASER WIRELESS LOANER

DEN-MAT HOLDINGS, LLC

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• Primary Device ID: D813444000L0
• NIH Device Record Key: e3d10ae2-0711-45d0-bca0-bf702b9a2d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCD BLUEWAVE LASER
• Version Model Number: 444000L
• Catalog Number: 444000L
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com
• Phone: 1-800-265-3444
• Email: info@clinicianschoice.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813444000L0 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2023-10-18
• Device Publish Date: 2023-10-10

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• D813444000L0 - CCD BLUEWAVE LASER: 2023-10-18CCD LASER WIRELESS LOANER
• D813444000L0 - CCD BLUEWAVE LASER: 2023-10-18 CCD LASER WIRELESS LOANER
• D8130561006970 - VAKT: 2023-04-26 VAKT ALIGNER UPR & LWR
• D8130303761050 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 5ml
• D8130303761100 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 10ml
• D8130562005300 - VAKT PRIVATE LABEL: 2023-03-14 VAKT ALIGNER UPPER
• D8130562005350 - ORTHOCLEAR - PL VAKT: 2023-03-14 VAKT ALIGNER LOWER
• D8130562005500 - VAKT PRIVATE LABEL: 2023-03-14 VAKT RETAINER UPPER
• D8130562005550 - VAKT PRIVATE LABEL: 2023-03-14 VAKT RETAINER LOWER