FDA.reportPublic FDA data

Rumex

Primary DI
00840159904930
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
11-024S
Catalog number
11-024S
Device description
Castroviejo Corneal Section Scissors, Right, 14.00 mm Blades, Lower Blade 0.50 mm Longer, Length 106 mm, Stainless Steel
Published
2020-06-03
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

Product Codes#

Code, Name table
CodeName
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159904930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159904930008401599049308401599049300840159904930

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, probe-like, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. It is available with various blade designs and sizes. 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
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 table
Primary DIBrandModelCatalogPublished
00840159901397Rumex4-072T4-072T2020-07-27
00840159901403Rumex4-0741S4-0741S2020-07-27
00840159901410Rumex4-0741T4-0741T2020-07-27
00840159901427Rumex4-090T4-090T2020-07-27
00840159901434Rumex4-091S4-091S2020-07-27
00840159901441Rumex4-092T4-092T2020-07-27
00840159901458Rumex4-111T4-111T2020-07-27
00840159901465Rumex4-113T4-113T2020-07-27
00840159901472Rumex4-121S4-121S2020-07-27
00840159901489Rumex4-122S4-122S2020-07-27
00840159901496Rumex4-123S4-123S2020-07-27
00840159901502Rumex4-136S4-136S2020-07-27
00840159901519Rumex4-140T4-140T2020-07-27
00840159901526Rumex4-171S4-171S2020-07-27
00840159901533Rumex4-175T4-175T2020-07-27
00840159901540Rumex4-176T4-176T2020-07-27
00840159901557Rumex4-177S4-177S2020-07-27
00840159901564Rumex4-185S4-185S2020-07-27
00840159901571Rumex4-185T4-185T2020-07-27
00840159901588Rumex4-1906T4-1906T2020-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
G2231135500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
G2231135900Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
00852194002045HAI ScissisorsHightech American Industrial Labs IncHNF2025-12-15
04059453156839Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453161697Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453162632Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
00190776415167MillenniumAvalign Technologies, Inc.HNF2025-12-03
09348811004185INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-12-02
04059453117205Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-09-25
04059453119780Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-08-25
00757770406401Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770419197Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770423040Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770417780Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483563Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483570Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770486175Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770492350Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770510603Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00194613003784MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613003791MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004101MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004316MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004682MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01