NV®PRO3 ZLR3003L

GUDID D813ZLR3003L0

NV PRO3 MICROLASER LOANER

DEN-MAT HOLDINGS, LLC

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• Primary Device ID: D813ZLR3003L0
• NIH Device Record Key: abc6cfa3-048e-465f-858d-5ae87d6cb5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NV®PRO3
• Version Model Number: ZLR3003L
• Catalog Number: ZLR3003L
• 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keey Dry
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813ZLR3003L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081214

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-01-05

On-Brand Devices [NV®PRO3 ]

• D813ZLR30080: NV PRO3 FOOTPEDAL
• D813ZLR30060: NV PRO3 MICRO BASE CHARGER
• D813ZLR3003L0: NV PRO3 MICROLASER LOANER
• D813ZLR30030: NV PRO3 MICROLASER