Icare tonometer probes

Basic Information

• Brand Name: Icare tonometer probes
• Primary DI: 06430033850565
• Version / Model: TP01s
• Company Name: ICARE FINLAND OY
• Labeler DUNS: 651755092
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-01
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: abcb24ee-8c10-42b8-893e-17f38d8df3b9
• Distribution End Date: 2016-12-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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: Yes
• 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
62405	Ophthalmic tonometer probe	A device intended to be attached to an ophthalmic tonometer and to make brief and gentle contact with the eye surface for the measurement of intraocular pressure (IOP). It may be in the form of a prism with a dedicated mount (mount may be included with the device) or a thin metal or plastic rod with a plastic distal tip designed to be moved towards the eye by the tonometer (e.g., via magnetization), which uses probe deceleration and rebound time measurements to calculate IOP. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430033850565	GS1

Premarket Submissions

Submission Number	Supplement Number
K063873	000
K153694	000