2.8 mm Disposable phaco set with 30° straight flared needle

Basic Information

• Brand Name: 2.8 mm Disposable phaco set with 30° straight flared needle
• Primary DI: 08717872031491
• Version / Model: 8430.28SF1
• Catalog Number: 8430.28SF1
• 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: 2020-02-17
• Public Version: 2
• Public Version Date: 2020-03-19
• Public Version Status: Update
• Public Device Record Key: 80acd422-9b07-4846-a16a-80ab20218314

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
HQC	Unit, Phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36215	Phacoemulsification system handpiece tip, single-use	A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	18717872031498	GS1
Primary	08717872031491	GS1

Premarket Submissions

Submission Number	Supplement Number
K190875	000