Diode Laser System Surgical Handpiece 6400105

GUDID 00647529000151

A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft tissue applications.

BIOLASE, INC.

Dental diode laser system
Primary Device ID00647529000151
NIH Device Record Key17839cbd-a1b5-4d25-92fc-6d95723d7f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser System Surgical Handpiece
Version Model Number6400105
Catalog Number6400105
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100647529000151 [Primary]
GS100647529000182 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


[00647529000151]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-08
Device Publish Date2016-09-22

On-Brand Devices [Diode Laser System Surgical Handpiece ]

00647529000199A kit containing two (2) reusable surgical handpieces intended for use with Diode Laser Systems
00647529000151A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical

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