Corneal Topographer HTG-1

Basic Information

• Brand Name: Corneal Topographer HTG-1
• Primary DI: 08800019600770
• Version / Model: HTG-1
• Catalog Number: HTG-1
• Company Name: Huvitz Co., Ltd.
• Labeler DUNS: 688154202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: fbb49e6f-af8e-4149-971c-23467b1fa821

Device Description

Corneal Topographer HTG-1

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	886.1350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18038	Corneal topography system	An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800019600770	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]