Sil-Ophtho

Basic Information

• Brand Name: Sil-Ophtho
• Primary DI: G601350T0
• Version / Model: 1
• Catalog Number: 350T
• Company Name: SIL-OPHTHO, LLC
• Labeler DUNS: 067465734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-14
• Public Version: 1
• Public Version Date: 2024-03-22
• Public Version Status: New
• Public Device Record Key: 12b2d1b0-5f13-4116-8223-b4590ff971bc

Device Description

A special viscosity silicone oil used as a lubricant for the prosthetic eye

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
HQH	Eye, Artificial, Non-Custom	Ophthalmic	886.3200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37280	Eyeball prosthesis lubricant	A material intended to be used for cleaning and lubricating an artificial eye. It is intended for use in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G601350T0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	6	Milliliter