Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017891009

FEI Number

3017891009

Entity Name

IANTREK INC.

City/State/Country

Providence, RI, US

Establishment Address

295 Promenade Street, Suite 101, Providence, RI 02908, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Iantrek Inc. (Owner Number: 10079930)

Owner / Operator Contact Address

295 Promenade Street, Suite 101, Providence, RI 02908, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-Rex AlloSert Canal AlloSert UVEO CycloPen Spannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2021-01-04
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-04

Official Correspondent

David Robson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Iantrek Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017891009. Last updated year: 2026. Please use registration number 3017891009 when referencing this establishment in official correspondence.