PICASSO PS001-PFW-RT

GUDID D746PS001PFWRT1

PICASSO 7.0 WATT DIODE Laser Package

RAINTREE ESSIX INC.

Dental diode laser system

• Primary Device ID: D746PS001PFWRT1
• NIH Device Record Key: b6bedbf8-1db2-4a95-a549-ca3b70f73b96
• Commercial Distribution Discontinuation: 2019-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PICASSO
• Version Model Number: PS001-PFW-RT
• Catalog Number: PS001-PFW-RT
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746PS001PFWRT1 [Primary]

FDA Product Code

• GEX: Powered laser surgical instrument

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: 2019-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [PICASSO]

• D746PS001PFWRT1: PICASSO 7.0 WATT DIODE Laser Package
• D746PL001PFWRT1: PICASSO LITE 2.5 WATT DIODE Laser Package
• D746PPLUS1: Picasso Plus Package with multi-tip handpiece
• D746PLPLUS1: Picasso Lite Plus Package with multi-tip handpiece