Hess Screen

Basic Information

• Brand Name: Hess Screen
• Primary DI: 05907642694886
• Version / Model: EH-1
• Company Name: MDT SP Z O O
• Labeler DUNS: 366126408
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-16
• Public Version: 1
• Public Version Date: 2025-07-24
• Public Version Status: New
• Public Device Record Key: d49247c3-7ced-44c8-bf19-9d315ea128f9

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOK	Screen, Tangent, Projection, Ac-Powered	Ophthalmic	886.1810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36398	Hess-screen	A tangent screen designed for manual testing of extra ocular muscle function (i.e., strabismus). It typically consists of a series of lines (Hess coordinates) configured in small sections in a curved pin-cushion pattern (i.e., the middle of the lines is closer to the centre of the screen than the ends of the lines) and is used in conjunction with a pair of goggles with a red and a green lens worn by the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05907642694886	GS1