FDA.reportPublic FDA data

Rumex

Primary DI
00840159900536
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
16-011
Catalog number
16-011
Device description
Kelly Descemet's Membrane Punch, 0.75 mm Diameter, Length 131 mm, Serrated Squeeze Action Titanium Handle
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNJPunch, Corneo-Scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159900536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159900536008401599005368401599005360840159900536

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

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
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
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00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613108816MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613110390MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
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00194613110994MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111397MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01