Primary Lens Set, 28D, 90D, 4 Mirror

Basic Information

• Brand Name: Primary Lens Set, 28D, 90D, 4 Mirror
• Primary DI: 00841668144275
• Version / Model: K31-3005
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-11
• Public Version: 1
• Public Version Date: 2024-04-19
• Public Version Status: New
• Public Device Record Key: ad0732cd-6c69-46aa-ab13-cc8f03b13140

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
HJL	Lens, condensing, diagnostic	Ophthalmic	886.1380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11894	Gonioscope	A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.	No	Active
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841668144275	GS1