Clement Clarke Ophthalmic

Basic Information

• Brand Name: Clement Clarke Ophthalmic
• Primary DI: 05060179470399
• Version / Model: 7005001
• Catalog Number: 7005001
• Company Name: HAAG-STREIT UK LIMITED
• Labeler DUNS: 504108242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 4
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: fd4a6bea-3094-4797-9fa9-fcc0f7eef951

Device Description

MADDOX WING TEST

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: No
• 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
HKW	Prism, Bar, Ophthalmic	Ophthalmic	886.1650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32716	Maddox wing	A hand-held, non-powered ophthalmic device intended to evaluate heterophoria/heterotropia, also known as strabismus or squint [i.e., a condition in which the eyes are pointing in slightly different directions (e.g., esophoria, exophoria, hyperphoria and/or cyclophoria)]. It is typically held by the patient, and consists of an eyepiece oriented towards a small board with a scale(s) [e.g., horizontal, vertical] and pointer(s), and a thin sheet (septum) which separates the board into two parts to create a different field of view for each eye (eye dissociation).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060179470399	GS1

Customer Contacts

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