FDA.reportPublic FDA data

Rumex

Primary DI
00840159902981
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
15-033
Catalog number
15-033
Device description
Fasanella Lacrimal Cannula, 23 Ga x 42.00 mm
Published
2020-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159902981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159902981008401599029818401599029810840159902981

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
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
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
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G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
G412CA14030MR PHACOCrestpoint Management LimitedHMX2025-05-27
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G412CA14050MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14070MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14080MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14090MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14100MR PHACOCrestpoint Management LimitedHMX2025-05-27
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G412CA14130MR PHACOCrestpoint Management LimitedHMX2025-05-27
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G412CA14150MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14160MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14170MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14180MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14190MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14200MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14210MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14220MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14230MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14240MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14250MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14260MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14270MR PHACOCrestpoint Management LimitedHMX2025-05-27