20GA Curved Laser Probe with Alcon adaptor

Basic Information

• Brand Name: 20GA Curved Laser Probe with Alcon adaptor
• Primary DI: 08717872013947
• Version / Model: 7010.ALC
• Catalog Number: 7010.ALC
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Labeler DUNS: 407522184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-07-26
• Public Version: 4
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 160affc7-cf8a-4549-9ab1-ace7e7710980

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

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
Primary	08717872013947	GS1
Unit of Use	18717872013944	GS1

Premarket Submissions

Submission Number	Supplement Number
K024061	000