Diode Laser Tips 6400605

GUDID 00647529003220

A starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic Pro Diode Laser Systems. The tips have the same length of 4 mm and core diameters of 300 and 400 µm.

BIOLASE, INC.

Dental diode laser system
Primary Device ID00647529003220
NIH Device Record Key3029f72d-06ca-4dbd-bcbe-c58db517df87
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser Tips
Version Model NumberPI Pro Tips, Starter Kit
Catalog Number6400605
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com

Device Dimensions

Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter
Outer Diameter300 Micrometer
Outer Diameter400 Micrometer
Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529003220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

[00647529003220]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2018-05-21

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