ProOcular Daily Disposable Contact Lens

Basic Information

• Brand Name: ProOcular Daily Disposable Contact Lens
• Primary DI: 10816816880609
• Version / Model: -7.5
• Company Name: CARLSBAD TECHNOLOGY INC.
• Labeler DUNS: 079113545
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 3
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 9033e2cd-7111-47ac-836b-6bf4e4963e04
• Distribution End Date: 2019-12-01

Device Description

ProOcular Daily Disposable Contact Lens Power -7.5

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MVN	Lens, Contact, (Disposable)	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47841	Soft corrective contact lens, daily-disposable	A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40816816880600	GS1	Carton	6	Not in Commercial Distribution	2019-12-01
Package	30816816880603	GS1	Case	24	Not in Commercial Distribution	2019-12-01
Primary	10816816880609	GS1
Unit of Use	00816816880602	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 46 – 86 Degrees Fahrenheit