Diode Laser Tips

GUDID 00647529001875

A single-use fiberoptic accessory intended for use with Epic surgical diode laser systems.

BIOLASE, INC.

General/multiple surgical laser system beam guide, single-use, non-sterile
Primary Device ID00647529001875
NIH Device Record Key17126d7e-e333-404c-8ec7-94f142832cec
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser Tips
Version Model NumberE4-100 EZ Tips
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

Length100 Millimeter
Length100 Millimeter
Length100 Millimeter
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter
Outer Diameter400 Micrometer
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529000403 [Primary]
GS100647529001875 [Package]
Contains: 00647529000403
Package: Box [5 Units]
In Commercial Distribution
GS100647529001950 [Package]
Contains: 00647529000403
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

Moist Heat or Steam Sterilization

[00647529001875]

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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00647529001868A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such
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