Diode Laser Tips

GUDID 00647529001936

A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.

BIOLASE, INC.

General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile General/multiple surgical laser system beam guide, single-use, non-sterile
Primary Device ID00647529001936
NIH Device Record Key3a83a754-8153-4e97-b7b9-935da02df774
Commercial Distribution Discontinuation2016-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDiode Laser Tips
Version Model NumberEpiTip 4-9 Perio
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
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

Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter
Outer Diameter400 Micrometer
Length9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529000458 [Primary]
GS100647529001936 [Package]
Contains: 00647529000458
Package: Box [30 Units]
Discontinued: 2016-11-30
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


[00647529001936]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-20
Device Publish Date2016-09-16

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00647529001943A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser
00647529001912A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser
00647529001929A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser
00647529001936A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser
00647529000441A single-use non-sterile fiberoptic pre-initiated tip intended for use with Biolase diode laser
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00647529001875A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems.
00647529001868A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such
00647529001837A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems
00647529002643A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000359A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529001806A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529001790A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems
00647529001783A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000311A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase diode laser sys
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00647529001844An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biola
00647529000137A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000120A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

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