DEVICE: NV®PRO3 (D813ZLR30080)

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Device Identifier (DI) Information

NV®PRO3
ZLR3008
ZLR3008
DEN-MAT HOLDINGS, LLC
D813ZLR30080
HIBCC
1
NV PRO3 FOOTPEDAL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental diode laser system A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite a diode to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to cut, excise, vaporize, and coagulate tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, diminish inflammation, oral therapy and tooth whitening. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keey Dry
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 6 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 14, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
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