Clement Clarke Ophthalmic

Basic Information

• Brand Name: Clement Clarke Ophthalmic
• Primary DI: 05060179470146
• Version / Model: 6403001ULUS
• Catalog Number: 6403001ULUS
• 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: 4
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 28d8da10-ee6c-46cc-b799-faa7f8e2be60

Device Description

SYNOPTOPHORE MODEL 2003 (11)

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
HJQ	Stereoscope, Ac-Powered	Ophthalmic	886.1870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36058	Synoptophore	An electrically-powered ophthalmic device intended to for the evaluation and training of a patient's binocular function, i.e., the ability of the two eyes to focus on a single object. It is used for diagnosing strabismus (squint), a deviation of the eye which the patient cannot overcome and present in variants such as stereoscopy (vision in depth), amblyopia otherwise known as lazy eye (dimness of vision without apparent disease of the eye), and diplopia [exotropia (outward eye deviation) or esotropia (one or both eyes turn inward)]. It typically consists of a base with twin vision tubes (adjustable in many axes) providing images and illumination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060179470146	GS1

Customer Contacts

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