Face Fixation Sticks (3pk)

Basic Information

• Brand Name: Face Fixation Sticks (3pk)
• Primary DI: B091153150
• Version / Model: 1
• Company Name: Gulden Ophthalmics Inc.
• Labeler DUNS: 002373249
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 1
• Public Version Date: 2023-07-13
• Public Version Status: New
• Public Device Record Key: edbf588b-ed61-4e1c-a10f-612d53e2ffa7

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: 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
HPL	Device, Fixation, Ac-Powered, Ophthalmic	Ophthalmic	886.1290	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64186	Ophthalmic examination target holder	A supportive device intended to be used during an ophthalmic examination (e.g., general eye test, dynamic retinoscopy, ophthalmoscopy) to hold a patient’s visual target in direct line of sight of the clinician, facilitating clinical observations and measurements along the visual axis. It is designed as a frame to support the visual target (e.g., mobile phone, eye test card) and has an opening through which eye observations are made; it typically includes connectors/clamps for fixation to an ophthalmic examination station and ophthalmic instruments. This device is typically used to help engage the patient when cooperation is difficult (e.g., a child or a person with a disability).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B091153150	HIBCC