NA

Basic Information

• Brand Name: NA
• Primary DI: 04582275250671
• Version / Model: CellChek 20-1 PLUS
• Company Name: KONAN MEDICAL, INC.
• Labeler DUNS: 690768619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-27
• Public Version: 1
• Public Version Date: 2023-10-05
• Public Version Status: New
• Public Device Record Key: 9795f528-c6f8-4c62-859a-f2fb3cf980d0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NQE	Microscope, Specular	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45729	Eye anterior segment analyser	A mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582275250671	GS1

Premarket Submissions

Submission Number	Supplement Number
K191558	000