FDA.reportPublic FDA data

Rumex

Primary DI
00840159902011
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
7-1061
Catalog number
7-1061
Device description
He Phaco Chopper, RHD, 45° Angled, Wedge Shaped, Round Handle, Length 120 mm, Round Titanium Handle
Published
2020-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159902011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159902011008401599020118401599020110840159902011

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
041546137
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840159900345Rumex18-30418-3042020-06-09
00840159900406Rumex18-30518-3052020-06-09
00840159900802Rumex18-30318-3032020-06-09
00840159903384Rumex18-30118-3012020-06-09
00840159903391Rumex18-301-118-301-12020-06-09
00840159903407Rumex18-30218-3022020-06-09
00840159903414Rumex18-30718-3072020-06-09
00840159903421Rumex18-30818-3082020-06-09
00840159903438Rumex18-31818-3182020-06-09
00840159905609Rumex18-30018-3002020-06-09
00840159907900Rumex18-300-118-300-12020-06-09
00840159907917Rumex18-303-118-303-12020-06-09
00840159907924Rumex18-305-118-305-12020-06-09
00840159907931Rumex18-31018-3102020-06-09
00840159907948Rumex18-31118-3112020-06-09
00840159907955Rumex18-31218-3122020-06-09
00840159907962Rumex18-31318-3132020-06-09
00840159907979Rumex18-31418-3142020-06-09
00840159902189Rumex9-011S9-011S2020-06-04
00840159902196Rumex9-012S9-012S2020-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395728MillenniumAvalign Technologies, Inc.HNQ2026-07-14
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21
00810163790454Diamatrix Ltd.DiamatrixHNQ2025-10-21
00190776412616MillenniumAvalign Technologies, Inc.HNQ2025-10-03
00190776412005MillenniumAvalign Technologies, Inc.HNQ2025-10-01
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00810163790331Diamatrix Ltd.DiamatrixHNQ2025-05-27
10649111487934Sklar InstrumentsSKLAR CORPORATIONHNQ2025-01-03
0084009621513727ga Dunn/Rice ILM Pick, Carbon Fiber Handle, BluntKATALYST SURGICAL LLCHNQ2023-10-16
G2231196710Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-09-19
00810123480883Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480890Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480906Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480913Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
G2231196700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-01-12