VERITAS SWIVEL PHACO HANDPIECE SYSTEM

Basic Information

• Brand Name: VERITAS SWIVEL PHACO HANDPIECE SYSTEM
• Primary DI: 05050474700888
• Version / Model: VRT691027
• Catalog Number: VRT691027
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 103021940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-16
• Public Version: 1
• Public Version Date: 2021-04-26
• Public Version Status: New
• Public Device Record Key: d080c655-5c45-46ba-acef-a66456d3af30

Device Description

VERITAS SWIVEL PHACO HANDPIECE SYSTEM

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34900	Phacoemulsification system handpiece	A holder for a dedicated detachable tip that together become a unit that delivers 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). This device will be activated by the surgeon using a foot control and may provide or facilitate the irrigation/suction systems needed for the removal of debris. The handpiece typically designed in the form of a pen or pencil. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050474700888	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: Low: 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: Low: 95 Percent (%) Relative Humidity