Diode Laser Tips 6400480

GUDID 00647529001844

An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Biolase, Inc.

Dental diode laser system
Primary Device ID00647529001844
NIH Device Record Keye345733f-b387-408b-80c3-a5e0781912b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser Tips
Version Model Numbereztips, surgical assortment kit, 30PK
Catalog Number6400480
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 Kitfalse
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

Device Dimensions

Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer
Length4 Millimeter
Outer Diameter400 Micrometer
Outer Diameter200 Micrometer
Outer Diameter300 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529001844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

[00647529001844]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

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