DEVICE: Diode Laser Tips (00064752900397)

Device Identifier (DI) Information

Diode Laser Tips
E4-60 EZ Tips
Not in Commercial Distribution

BIOLASE, INC.
00064752900397
GS1
May 20, 2018
1
152165700 *Terms of Use
A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130465 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 60 Millimeter
Outer Diameter: 400 Micrometer
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Device Record Status

d03c3c27-2bd1-41ba-ac18-a2848b2a70c0
July 06, 2018
4
September 16, 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
00647529001868 3 00064752900397 2018-05-20 Not in Commercial Distribution Box
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-321-6717
Diodeservice@biolase.com
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