Bausch + Lomb

Basic Information

• Brand Name: Bausch + Lomb
• Primary DI: 00310119080481
• Version / Model: 628048
• Catalog Number: 628048
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-17
• Public Version: 2
• Public Version Date: 2024-01-10
• Public Version Status: Update
• Public Device Record Key: 5460b1ee-5771-493c-85bf-4966862d5378
• Distribution End Date: 2020-12-28

Device Description

1 Scleral Contact Lens Case

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: 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
LRX	Case, Contact Lens	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16581	Contact lens case	A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310119080481	GS1