Bausch + Lomb

Basic Information

• Brand Name: Bausch + Lomb
• Primary DI: 10757770484949
• Version / Model: CX9623
• Catalog Number: CX9623
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 3ac248c2-4fb1-4933-bf69-a8ffa4b01401

Device Description

LIGHT PIPE, 23GA 6/BX

Device Characteristics

• Single Use: Yes
• 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
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	886.4150	2
HQC	Unit, Phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45193	Ophthalmic fibreoptic light instrument, single-use	A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10757770484949	GS1
Unit of Use	00757770484942	GS1