ST500 Remote

Basic Information

• Brand Name: ST500 Remote
• Primary DI: 06430033851807
• Version / Model: TR01
• Company Name: ICARE FINLAND OY
• Labeler DUNS: 651755092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-07
• Public Version: 1
• Public Version Date: 2024-11-15
• Public Version Status: New
• Public Device Record Key: 89153f33-db40-408f-ba31-452a588c9d4f

Device Description

ST500 Remote

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKX	Tonometer, Ac-Powered	Ophthalmic	886.1930	2
HKY	Tonometer, Manual	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66864	Ophthalmic tonometer remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an ophthalmic tonometer (e.g., brightness, start, stop, program select) from a distance wirelessly [e.g., via Bluetooth connection]. It is intended to be operated by the healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430033851807	GS1

Premarket Submissions

Submission Number	Supplement Number
K241447	000