APX 200

Basic Information

• Brand Name: APX 200
• Primary DI: 17290017069002
• Version / Model: 200
• Catalog Number: 200-300
• Company Name: APX OPHTHALMOLOGY LTD
• Labeler DUNS: 600070283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-14
• Public Version: 1
• Public Version Date: 2021-04-22
• Public Version Status: New
• Public Device Record Key: 41aa3f3a-f354-47f0-a61f-883f99e8f272

Device Description

The APX200 is a single patient, single use device, intended to provide expansion of the pupillary aperture.

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: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNQ	Hook, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46698	Intraocular retractor, single-use	A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290017069002	GS1
Package	27290017069009	GS1	6 Units Package	6	In Commercial Distribution
Package	37290017069006	GS1	3 Units Package	3	In Commercial Distribution

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius