ST500 SmartCradle

Basic Information

• Brand Name: ST500 SmartCradle
• Primary DI: 06430033851784
• Version / Model: TX02
• 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: 5be06669-ebab-48b9-8d63-e582b085bdee

Device Description

ST500 SmartCradle

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
64667	Noninvasive device battery charger/transceiver/cable	An electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430033851784	GS1

Premarket Submissions

Submission Number	Supplement Number
K241447	000