Retinoscopy Rack

Basic Information

• Brand Name: Retinoscopy Rack
• Primary DI: B091151610
• 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: 877cd9aa-23ad-4051-986f-d095ca9c9ab6

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: No
• Has Manufacturing Date: No
• 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
HMH	Rack, Skiascopic	Ophthalmic	886.1750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36068	Trial lens set	A set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B091151610	HIBCC