G.o.c.c.l.e.s. 531000601

GUDID 08051040582003

The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. light proprietary light source, in order to allows the examination of autofluorescence of the oral cavity and consequently detect oral abnormalities such as dysplastic or anaplastic lesions (carcinomas of the oral mucosa).

PIERREL SPA

Oral lesion examination light
Primary Device ID08051040582003
NIH Device Record Keye166c533-30e9-4a82-9246-504d6ef2589d
Commercial Distribution StatusIn Commercial Distribution
Brand NameG.o.c.c.l.e.s.
Version Model NumberG.o.c.c.l.e.s.
Catalog Number531000601
Company DUNS458463044
Company NamePIERREL SPA
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

Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com
Phone+390823626111
Emailf.velotti@pierrelgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108051040582003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXVDiagnostic Light, Soft Tissue Detector

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-23
Device Publish Date2016-10-21

Devices Manufactured by PIERREL SPA

08051040582003 - G.o.c.c.l.e.s.2023-06-23The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. light proprietary light source, in order to allows the examination of autofluorescence of the oral cavity and consequently detect oral abnormalities such as dysplastic or anaplastic lesions (carcinomas of the oral mucosa).
08051040582003 - G.o.c.c.l.e.s.2023-06-23 The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. ligh
08051040582010 - G.o.c.c.l.e.s. light2023-06-23 G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s eyewear in order to allow the illumina

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