Ultrafast Diode Laser 7300100

GUDID 00860179001044

Ultrafast Diode Laser

Dentlight Inc.

General/multiple surgical diode laser system
Primary Device ID00860179001044
NIH Device Record Key99c39b2d-791b-4f78-9f1b-d16f2d3becdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrafast Diode Laser
Version Model Number7300100
Catalog Number7300100
Company DUNS171208585
Company NameDentlight 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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860179001044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVKLaser, Dental, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


[00860179001044]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-01
Device Publish Date2022-01-24

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