UNFOLDER PLATINUM 1 SERIES

Basic Information

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• Primary DI: 05050474540323
• Version / Model: 1MTEC30
• Catalog Number: 1MTEC30
• 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: 2019-02-13
• Public Version: 2
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: 4e65b3f0-b9e9-427f-ac87-cf2836a33524

Device Description

UNFOLDER PLATINUM 1 SERIES CRTRDG 30/BOX

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYB	LENS, GUIDE, INTRAOCULAR	Ophthalmic	886.4300	1

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15050474540320	GS1	Box	30	In Commercial Distribution
Primary	05050474540323	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081545	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius