FDA.reportPublic FDA data

Rumex

Primary DI
00840159905999
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
2-062S
Catalog number
2-062S
Device description
Rumex Internal Micro Incision Gauges, 16 Blades 1.00 - 2.50 mm, Length 75 mm, Stainless Steel
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLNGauge, Lens, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLNGauge, Lens, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159905999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159905999008401599059998401599059990840159905999

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic angular gauge, reusableA non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. 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
00842331190995Novo SurgicalNOVO SURGICAL, INC.HLN2023-12-18
00810799037602Stephens InstrumentsKRISHNA IMPORTS INCHLN2020-09-22
00840159901106RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903148RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903919RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903926RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159903933RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159905975RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159905982RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159906002RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908549RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908556RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
00840159908563RumexRUMEX INTERNATIONAL CORP.HLN2020-05-29
06945033901990TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLN2018-09-24
06945033902003TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLN2018-09-24