Waterlase Laser Tips 7200800

GUDID 00064529001028

A tip kit containing 2 reusable sapphire tips intended for use with Waterlase laser delivery systems. The tips have the same core diameter of 600 mi

BIOLASE, INC.

General/multiple surgical laser system beam guide, reusable
Primary Device ID00064529001028
NIH Device Record Key606974fc-6984-4926-b5db-8f0bc3a96400
Commercial Distribution Discontinuation2018-05-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWaterlase Laser Tips
Version Model NumberMC6
Catalog Number7200800
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 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
EmailWaterlaseservice@biolase.com

Device Dimensions

Outer Diameter600 Micrometer
Length4 Millimeter
Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100064529001028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00064529001028]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-06
Device Publish Date2016-09-22

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