Diode Laser Tips 6400605

GUDID 00617529003220

A tip 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

BIOLASE, INC.

Dental diode laser system Dental diode laser system
Primary Device ID00617529003220
NIH Device Record Key84c5286c-9366-4516-b016-15ee69fadb7c
Commercial Distribution Discontinuation2018-05-21
Commercial Distribution StatusNot in 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 n
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100617529003220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00617529003220]

Moist Heat or Steam Sterilization


[00617529003220]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-08
Device Publish Date2017-01-13

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