VitreQ

Basic Information

• Brand Name: VitreQ
• Primary DI: 08719214222628
• Version / Model: LP27.I04
• Company Name: Vitreq B.V.
• Labeler DUNS: 491393613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-12
• Public Version: 1
• Public Version Date: 2019-05-20
• Public Version Status: New
• Public Device Record Key: 0cf7fc3c-4232-49fb-8110-398c303f733c

Device Description

27G 90° Directional Laser Probes, Iridex® Style

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2
HQB	Photocoagulator And Accessories	Ophthalmic	886.4690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61162	Ophthalmic laser system beam guide	A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08719214222611	GS1	Box	5	In Commercial Distribution
Primary	08719214222628	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]