SMARTLOAD

Basic Information

• Brand Name: SMARTLOAD
• Primary DI: 05050474621558
• Version / Model: GAB00
• Catalog Number: GAB0000085
• 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: 2020-09-01
• Public Version: 2
• Public Version Date: 2023-10-03
• Public Version Status: Update
• Public Device Record Key: 6ad2e3b9-6496-42e2-a59c-dd105eaa23af

Device Description

SMARTLOAD SENSAR 1PC CLEAR MONO 8.5D

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: No
• 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
HQL	intraocular lens	Ophthalmic	886.3600	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47726	Intraocular lens-insertion cartridge	A sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.	No	Active
35658	Posterior-chamber intraocular lens, pseudophakic	An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050474621558	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			OPTICAL POWER:8.50 DIO
Device Size Text, specify			OPTICAL ZONE DIAMETER:6.00 mm
Outer Diameter	13.00	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP AWAY FROM SUNLIGHT