MCNEILL-GOLDMAN SCLERAL FIXATION RING

Basic Information

• Brand Name: MCNEILL-GOLDMAN SCLERAL FIXATION RING
• Primary DI: 00192896012189
• Version / Model: 10-3314
• Catalog Number: 10-3314
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-18
• Public Version: 2
• Public Version Date: 2019-05-13
• Public Version Status: Update
• Public Device Record Key: aba3bfeb-bf8b-4504-b689-998f5fab8bc0

Device Description

MCNEILL-GOLDMAN SCLERAL FIXATION RING/BLEPHAROSTAT LARGE SIZE

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: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNI	Retractor, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32758	Flieringa ophthalmic ring	A circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896012189	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	17	Millimeter