AccessGUDID - DEVICE: Tran Goniowash (EFABTG012)

GUDID

Device Identifier (DI) Information

Brand Name: Tran Goniowash
Version or Model: TG01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fabrinal SA

Primary DI Number: EFABTG012
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483267576 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Humidity: between 20 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d3c211c-9aee-40de-ae49-740b9895b51a
Public Version Date: June 03, 2025
Public Version Number: 1
DI Record Publish Date: May 26, 2025