LAMINAR

Basic Information

• Brand Name: LAMINAR
• Primary DI: 05050474573307
• Version / Model: OPOR4521R
• Catalog Number: OPOR4521R
• 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: 2017-06-05
• Public Version: 4
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: cef8e897-99b3-48d6-af7e-edd0c344d92a

Device Description

21 GA LAMINAR PHACO TIP 45D SL REUSABLE

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: Yes
• 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
34901	Phacoemulsification system handpiece tip, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050474573307	GS1
Package	35050474573308	GS1	Box	6	In Commercial Distribution

Customer Contacts

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