v300H Vision System

GUDID 00867009000413

Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.

SYRIS SCIENTIFIC LLC

Head-worn lamp

• Primary Device ID: 00867009000413
• NIH Device Record Key: b5f153be-091f-4855-9dcb-6ea005ba49e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: v300H Vision System
• Version Model Number: v300H
• Company DUNS: 043184204
• Company Name: SYRIS SCIENTIFIC LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com
• Phone: 207-657-7050
• Email: pwilkinson@syrisscientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867009000413 [Primary]

FDA Product Code

• KZF: Device, Medical Examination, Ac Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-12-04

Devices Manufactured by SYRIS SCIENTIFIC LLC

• 00867009000406 - v900L Vision System: 2019-02-07 Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.
• 00867009000413 - v300H Vision System: 2019-02-07Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.
• 00867009000413 - v300H Vision System: 2019-02-07 Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.