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 Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light

• Primary Device ID: 08051040582003
• NIH Device Record Key: e166c533-30e9-4a82-9246-504d6ef2589d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G.o.c.c.l.e.s.
• Version Model Number: G.o.c.c.l.e.s.
• Catalog Number: 531000601
• Company DUNS: 458463044
• Company Name: PIERREL SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com
• Phone: +390823626111
• Email: f.velotti@pierrelgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051040582003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151630

FDA Product Code

• NXV: Diagnostic Light, Soft Tissue Detector

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-23
• Device Publish Date: 2016-10-21

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. light: 2023-06-23 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