ML7030 (Minus 20) ML7030 (-20)

GUDID 00850724001322

Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample

MED LOGICS INC

Keratome blade, single-use
Primary Device ID00850724001322
NIH Device Record Key20c66837-d007-43ac-bdcc-6cca8f63bcde
Commercial Distribution StatusIn Commercial Distribution
Brand NameML7030 (Minus 20)
Version Model NumberML7030 (-20)
Catalog NumberML7030 (-20)
Company DUNS075390489
Company NameMED LOGICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com
Phone9495823891
Emailjustin.ross@mlogics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850724001322 [Primary]
GS110850724001329 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HNOKeratome, Ac-Powered
KYGDevice, Irrigation, Ocular Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


[00850724001322]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-29
Device Publish Date2020-07-21

Devices Manufactured by MED LOGICS INC

10850724001107 - Vacuum Tubing2020-09-07 Disposable Microkeratome Vacuum Tubing
00850724001902 - ML7 Eye Marker2020-09-07 Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring
00850011743997 - Wrench, Helical Drive, ML72020-09-04 Wrench use to adjust helical screw on the ML7 Vacuum Rings
10850724001206 - Vacuum Tubing2020-09-04 Disposable Tubing for use with the ML7 Microkeratome
00850724001681 - ML7 Microkeratome2020-09-04 Console for use with the ML7 microkeratome
00850724001780 - Footswitch, ML72020-09-04 Footswitch for use with the ML7 microkeratome
00850724001803 - Handpiece, ML72020-09-04 Handpiece for use with the ML7 Microkeratome
00850724001810 - Sterilization Tray, ML72020-09-04 Sterilization tray for use with the ML7 microkeratome

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