Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058726

FEI Number

1000307733

Entity Name

RUMEX INTERNATIONAL CO.

City/State/Country

Tampa, FL, US

Establishment Address

14240 Carlson Circle, Building K, Suite 8, Tampa, FL 33626, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Rumex International Co. (Owner Number: 9011770)

Owner / Operator Contact Address

14240 Carlson Circle, Building K, Suite 8, Tampa, FL 33626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RUMEX OPHTHALMIC INSTRUMENTS Rumex Instruments RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS OPHTHALMIC TREPHINE Rumex Instruments RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC HOOK RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex ophthalmic instruments OPHTHALMIC CURETTE RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS Rumex Probes GONIOSCOPE GOLDMAN INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Rumex Director RUMEX REUSABLE OPHTHALMIC INSTRUMENTS Markes, Reusable Ophthalmic Instruments Rumex ophthalmic instruments RUMEX OPHTHALMIC INSTRUMENTS Diamond Knife Cleaning Pack RUMEX CARDIOVASCULAR INSTRUMENTS Dissector RUMEX OPHTHALMIC INSTRUMENTS DRAPE CLAMP SERREFINE LACHRYMAL DILATOR Instruments, Surgical, Cardiovascular RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS Injector RUMEX OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS OPHTHALMIC SPATULA RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS EYE SHIELD ALGER BRUSH RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS RUMEX CARDIOVASCULAR INSTRUMENTS RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC FORCEPS RUMEX OPHTHALMIC INSTRUMENTS Scissors, General Rumex Intsruments RUMEX CARDIOVASCULAR INSTRUMENTS FIXATION RING RING OPTHALMIC RUMEX OPHTHALMIC INSTRUMENTS RUMEX OPHTHALMIC CANNULA RUMEX OPHTHALMIC INSTRUMENTS RUMEX REUSABLE OPHTHALMIC INSTRUMENTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2020-02-11
JXS	Block, Cutting, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	2025-03-28
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
FCT	Headlight, Fiberoptic Focusing	Ophthalmic	Class 2	886.4335	2020-01-15
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2025-04-01
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-02-01
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-01-15
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-06-20
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-01-15
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2025-12-19
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-01-15
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2023-04-19
HKS	Prism, Gonioscopic	Ophthalmic	Class 1	886.1660	1998-02-26
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-02-11
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2023-04-19
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2018-02-07
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2018-02-07
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2025-12-19
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2006-06-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-11-15
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-01-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-01-14
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2020-01-15
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-06-20
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2006-06-20
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2009-12-10
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-02-11
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-01-15
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2020-01-15
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2020-01-14
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-01-15
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2018-02-07
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2006-06-20
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2020-01-15
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2020-01-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2006-06-20
HIY	Brush, Haidinger, (Including Macular Integrity)	Ophthalmic	Class 1	886.1090	2006-06-20
ISN	Cable	Physical Medicine	Class 1	890.3420	2020-01-15
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2020-01-15
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2018-02-07
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-06-20
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2025-04-10
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-01-15
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	1998-02-26
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-06-20
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2020-01-15
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2018-02-07

Official Correspondent

Inessa Cellentani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rumex International Co.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031231776	Perfect Ophthalmic Instruments FZE	Dubai Dubayy, AE
3012185136	RUMEX Baltics SIA	Riga, LV

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
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-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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.

Similar Registrations

Registration Number	Establishment Name	Location
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
3009170227	INDUSBELLO INDUSTRIA DE INSTRUMENTOS ODO	Londrina Parana, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058726. Last updated year: 2026. Please use registration number 1058726 when referencing this establishment in official correspondence.