Clement Clarke Ophthalmic

Basic Information

• Brand Name: Clement Clarke Ophthalmic
• Primary DI: 05060179470344
• Version / Model: 6908000US
• Catalog Number: 6908000US
• Company Name: HAAG-STREIT UK LIMITED
• Labeler DUNS: 504108242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 3
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: f5e06757-4fc0-4b3a-8796-7c5785766ceb

Device Description

ELECTRIC HESS SCREEN MK2B

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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	05060179470344	GS1

Customer Contacts

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