PENTAX

Basic Information

• Brand Name: PENTAX
• Primary DI: 04961333169047
• Version / Model: OF-D3
• Company Name: HOYA CORPORATION
• Labeler DUNS: 691519705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: 2c8ade72-88a7-4ae5-a550-aba0f63b903c

Device Description

Eyeshield OF-D3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• 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
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65470	Scope eyepiece attachment	A soft contouring device intended to be attached to the eyepiece of a medical scope (e.g., endoscope, ophthalmoscope, microscope) to provide comfort for, or assist positioning of, the eye during use of the scope; it is not a storage cover. It may be in the form of a covering, brow rest, or eyecup and is typically intended for contact with a healthcare professional while performing a procedure, but some types are intended for contact with the patient while being viewed with an opthalmoscope; it does not include optics. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333169047	GS1

Premarket Submissions

Submission Number	Supplement Number
K850020	000