Flieringa Scleral Fixation Ring, 18mm

Basic Information

• Brand Name: Flieringa Scleral Fixation Ring, 18mm
• Primary DI: 00840096207484
• Version / Model: 8800-18
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-09
• Public Version: 1
• Public Version Date: 2020-06-17
• Public Version Status: New
• Public Device Record Key: 79d88add-49e3-406d-b807-9383f00b2153

Device Description

Flieringa Scleral Fixation Ring, 18mm

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62917	Eyeball fixation instrument, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840096207484	GS1