ScleralFil

Basic Information

• Brand Name: ScleralFil
• Primary DI: 00310119303696
• Version / Model: TBD
• Catalog Number: 630369
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 1
• Public Version Date: 2023-07-13
• Public Version Status: New
• Public Device Record Key: b56c5ba9-0108-4787-a05e-f6c96ec1f027

Device Description

Contact Lens Sterile Saline Solution

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	886.5918	2
LPN	Accessories, Soft Lens Products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45866	Rigid contact lens cleaning solution	An aqueous formulation containing appropriate agents for loosening debris from rigid gas permeable (RGP) or hard contact lenses, often with a gentle rubbing of the lenses. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. 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	00310119303696	GS1