Harms Trabeculotome Set

Basic Information

• Brand Name: Harms Trabeculotome Set
• Primary DI: 04058935011802
• Version / Model: E0421
• Company Name: Bausch & Lomb GmbH
• Labeler DUNS: 344609518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-11
• Public Version: 1
• Public Version Date: 2025-07-21
• Public Version Status: New
• Public Device Record Key: 1aea5049-7f7e-42bf-b12c-4c94f4ee8b0a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNR	Forceps, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32751	Trabeculotome, reusable	A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy [surgical opening of the sinus venosus sclerae (Schlemm’s canal)] to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is typically made of high-grade stainless steel, having a two-pronged fork at the distal end and a handle at the proximal end. It enables guided unroofing of Schlemm's canal (an endothelium-lined tube) through insertion of one of the prongs via incisions and flaps made in the eye. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04058935011802	GS1