Rumex

Primary DI: 00840159906569
Brand: Rumex
Company: RUMEX INTERNATIONAL CORP.
Model: 7-080/90
Catalog number: 7-080/90
Device description: I/A Tip, Angled 90°, Stainless Steel
Published: 2020-06-09
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Product Codes

Code	Name
KYG	Device, Irrigation, Ocular Surgery

Product Code Classifications

Code	Device	Specialty	Class
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00840159906569	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00840159906569	00840159906569	840159906569	0840159906569

GMDN Terms

Term	Definition
Surgical irrigation/aspiration handpiece, reusable	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Term

Definition

Surgical irrigation/aspiration handpiece, reusable

A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number: 041546137
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: true

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
00840159901397	Rumex	4-072T	4-072T	2020-07-27
00840159901403	Rumex	4-0741S	4-0741S	2020-07-27
00840159901410	Rumex	4-0741T	4-0741T	2020-07-27
00840159901427	Rumex	4-090T	4-090T	2020-07-27
00840159901434	Rumex	4-091S	4-091S	2020-07-27
00840159901441	Rumex	4-092T	4-092T	2020-07-27
00840159901458	Rumex	4-111T	4-111T	2020-07-27
00840159901465	Rumex	4-113T	4-113T	2020-07-27
00840159901472	Rumex	4-121S	4-121S	2020-07-27
00840159901489	Rumex	4-122S	4-122S	2020-07-27
00840159901496	Rumex	4-123S	4-123S	2020-07-27
00840159901502	Rumex	4-136S	4-136S	2020-07-27
00840159901519	Rumex	4-140T	4-140T	2020-07-27
00840159901526	Rumex	4-171S	4-171S	2020-07-27
00840159901533	Rumex	4-175T	4-175T	2020-07-27
00840159901540	Rumex	4-176T	4-176T	2020-07-27
00840159901557	Rumex	4-177S	4-177S	2020-07-27
00840159901564	Rumex	4-185S	4-185S	2020-07-27
00840159901571	Rumex	4-185T	4-185T	2020-07-27
00840159901588	Rumex	4-1906T	4-1906T	2020-07-27

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
B090MT2021	MorTan	ZIEN MEDICAL TECHNOLOGIES, INC.	KYG	2026-02-10
00757770636266	Bausch + Lomb	Bausch & Lomb Incorporated	KYG	2025-08-05
00757770483402	Bausch + Lomb	Bausch & Lomb Incorporated	KYG	2025-07-29
00757770492329	Bausch + Lomb	Bausch & Lomb Incorporated	KYG	2025-07-29
B090MT20001	MorTan	ZIEN MEDICAL TECHNOLOGIES, INC.	KYG	2025-06-25
B090MT66730	MorTan	ZIEN MEDICAL TECHNOLOGIES, INC.	KYG	2025-06-25
00757770406463	Bausch + Lomb	Bausch & Lomb Incorporated	KYG	2024-11-21
00194613022938	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613022945	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613023959	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613023973	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613044817	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613044824	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613046101	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613060091	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613060633	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613088057	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
00194613090340	MSI Precision Specialty Instruments	Med Saver, Inc.	KYG	2024-08-15
G223IAT3S45	Medetz Surgical Instruments	Medetz Surgical Instruments LLC	KYG	2024-06-17
G223IAT3S450	Medetz Surgical Instruments	Medetz Surgical Instruments LLC	KYG	2024-05-23
08058340220710	Set Bi-manual I/A Handpieces 23G	AKTIVE SRL	KYG	2024-01-11
08058340220727	Set Bi-Manual I/A Handpieces 21G	AKTIVE SRL	KYG	2024-01-11
08058340220734	Passive Reservoir	AKTIVE SRL	KYG	2024-01-11
08058340220741	Active Reservoir	AKTIVE SRL	KYG	2024-01-11
08056477557518	Dual Bore Cannula 27G	AKTIVE SRL	KYG	2024-01-11
08056477559598	Dual Bore Cannula 23G, 36mm	AKTIVE SRL	KYG	2023-12-19
08058340220994	Dual Bore Cannula 20G	AKTIVE SRL	KYG	2023-12-19
08058340221007	Dual Bore Cannula 23G	AKTIVE SRL	KYG	2023-12-19
08058340221014	Dual Bore Cannula 25G	AKTIVE SRL	KYG	2023-12-19
08056477559604	Dual Bore Cannula 25G, 36mm	AKTIVE SRL	KYG	2023-12-19