Rumex 16-0306

GUDID 00840159907764

Corneal Trephine Blades, 7.75 mm, Stainless Steel

RUMEX INTERNATIONAL CORP.

LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable LASEK alcohol well, reusable
Primary Device ID00840159907764
NIH Device Record Key7751b720-8dc6-4e08-a53c-347f795c0542
Commercial Distribution StatusIn Commercial Distribution
Brand NameRumex
Version Model Number16-0306
Catalog Number16-0306
Company DUNS041546137
Company NameRUMEX INTERNATIONAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]
GS100840159907764 [Primary]

FDA Product Code

HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic
HRHTrephine, Manual, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


[00840159907764]

Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [Rumex]

00840159908563Ruler, Stainless Steel
00840159908556Helveston Scleral Ruler
00840159908549Helveston Scleral Ruler
00840159906002Adler Wound Gauge, 2.00 - 2.50 mm Ranges, Titanium
00840159905999Rumex Internal Micro Incision Gauges, 16 Blades 1.00 - 2.50 mm, Length 75 mm, Stainless Steel
00840159905982Grooved Mendez Degree, With 4 Grooves, 13.00/19.00 mm Diameters, Length 136 mm, Titanium
00840159905975LRI Gauge, With Atraumatic Fixation Teeth, 13.00/19.00 mm Diameters, Length 134 mm, Titanium
00840159905647LASEK Funnel 9.50 mm, Titanium, Length 120 mm
00840159905630LASEK Funnel 8.50 mm, Titanium, Length 120 mm
00840159905586Davis Foreign Body Spud, Length 130 mm, Round Titanium Handle
00840159904404Lester Lens Manipulator, Straight, 0.20 mm Hourglass Shaped Tip, Length 124 mm, Round Titanium H
00840159904398Lewicky Hook, Angled, 0.15mm x 10.00 mm Shaft, Length 120 mm, Round Titanium Handle
00840159904381Iris Hook, 1.00 mm, Angled, Length 121 mm, Round Titanium Handle
00840159903933Degree gauge With Beveled Face, 12.00/16.00 mm Diameters, Length 132mm, Titanium
00840159903926Grooved Fine Mendez Degree Gauge, With 4 Grooves, 12.00/14.00 mm Diameters, Length 120 mm, Titan
00840159903919Grooved Mendez Degree Gauge, With 4 Grooves, 13.00/16.50 mm Diameters, Length 122 mm, Titanium
00840159903148Maloney Intraoperative Keratometer, Titanium
00840159902004Drysdale Nucleus Manipulator, Capsule Polisher Tip, Round Handle, Length 121 mm, Round Titanium
00840159901991Drysdale Nucleus Manipulator, Regular Tip, Round Handle, Length 121 mm, Round Titanium Handle
00840159901984Fukasaku Small Pupil Snapper Hook And Chopper, Round Handle, Length 121 mm, Round Titanium Handl
00840159901779Stevens Curved Tenotomy Hook, 6.00 mm Flat Hook, Length 120 mm, Flat Titanium Handle
00840159901762Gass Retinal Detachment Hook, 13.00 mm Flat Hook, 1.50 x 0.70 mm Hole, Length 140 mm, Flat Titan
00840159901755Graefe Muscle Hook, Size 2, 1.50x10.00 mm Hook, Length 140 mm, Flat Titanium Handle
00840159901748Graefe Muscle Hook, Size 1, 1.00x8.00 mm Hook, Length 140 mm, Flat Titanium Handle
00840159901731Jameson Muscle Hook, 2.00 mm Bulbous Tip, 9.50 mm Flat Hook, Length 135 mm, Round Titanium Handl
00840159901724Bechert Nucleus Rotator, Angled, "Y" Shaped Tip, Length 121 mm, Round Titanium Handle
00840159901717Reversed Sinskey Hook, Angled, 0.15x10.00 mm Shaft, Length 116 mm, Round Titanium Handle
00840159901700Rumex Lens Manipulator, Button Shaped Tip 0.45 mm, Angled, Length 122 mm, Round Titanium Handle
00840159901106Mendez Degree Gauge, Round Handle, Length 134 mm, Titanium
00840159900796Kuglen Iris Hook, Angled, "H" Shaped Tip, Length 122 mm, Round Titanium Handle
00840159900772Lester Lens Manipulator, Angled, 0.20 mm Hourglass Shaped Tip, Length 122mm, Round Titanium Hand
00840159900352Sinskey Hook, Angled, 0.15mm x 10.00 mm Shaft, Length 122mm, Round Titanium Handle
00840159910276Castroviejo Needle Holder, Standart Jaws, Gripping Surface 11.00 mm, Curved, With Lock, Length 1
00840159910269Castroviejo Needle Holder, Delicate jaws 13.5mm, 125 mm Length, Straight, With Lock, Stainless S
00840159910252Barraquer Needle Holder, Fine Jaws 12.00 mm, Curved Without Lock, Medium Size, Length 115 mm, St
00840159910047Disposable Eye Shields, non sterile, 50 per Box
00840159909706Kozlov Trabeculectomy Flap Marker, Tapered Blades
00840159909645Crozafon Prechopper, Round Handle, Length 118 mm, Stainless Steel
00840159909515Curved Subretinal Scissors, Attached To A Universal Handle, with a Flushing System, 25 Ga
00840159909508Vertical Vitreoretinal Scissors, Attached To A Universal Handle, with a Flushing System, 25 Ga
00840159909492Grandon T Incision Marker
00840159909300LRI Axis Marker, Pre-Op Reference Marker, Horizontal Axis 3' and 9', Length 120 mm, Titanium
00840159908600Optical Zone Marker, Quadrant Markings at 3,5,7 mm
00840159908594LRI Marker, 6.00 x 8.00 mm Chord Lengths, With Degree Gauges, Length 130 mm, Titanium
00840159908587Anis Suture Placement Marker
00840159908570Osher-Neuman Low Profile Corneal Marker, 16 Lines, Stainless Steel
00840159907894Lid Plate, 20.00 mm and 24.00 mm Wide, Nonreflective Surface, Length 110 mm, Titanium
00840159906927Side Curved Vitreoretinal Scissors, 20 Ga, Tip Only
00840159906910Straight Vitreoretinal Scissors, Attached To A Universal Handle, with a Flushing System, 23 Ga
00840159906903Straight Vitreoretinal Scissors, Rounded Blades, 20 Ga, Tip Only

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