Tran Goniowash

Basic Information

• Brand Name: Tran Goniowash
• Primary DI: EFABTG012
• Version / Model: TG01
• Company Name: Fabrinal SA
• Labeler DUNS: 483267576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-26
• Public Version: 1
• Public Version Date: 2025-06-03
• Public Version Status: New
• Public Device Record Key: 6d3c211c-9aee-40de-ae49-740b9895b51a

Device Description

Tran Goniowash is a single-use irrigation cannula for washing the anterior chamber of the eye, especially the trabecular meshwork and the iridocorneal angle following a cataract surgery. Tran Goniowash is compatible with the Goniowash washing technique.

Device Characteristics

• Single Use: Yes
• 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: 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
HMX	Cannula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46705	Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use	A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EFABTG011	HIBCC		5	In Commercial Distribution
Primary	EFABTG012	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity