FDA.reportPublic FDA data

ML7030 (Minus 10)

Primary DI
00850724001032
Brand
ML7030 (Minus 10)
Company
MED LOGICS INC
Model
ML7030 (-10)
Catalog number
ML7030 (-10)
Device description
Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample
Published
2020-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNOKeratome, Ac-Powered
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010872000ML BLADE, MODEL ML7030Med-Logics, Inc.2001-06-22HNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850724001039PackageGS110In Commercial Distribution
00850724001032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085072400103910850724001039
00850724001032008507240010328507240010320850724001032

GMDN Terms#

Term, Definition table
TermDefinition
Keratome blade, single-useA surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
9495823891justin.ross@mlogics.com

Regulatory Flags#

DUNS number
075390489
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850724001100Vacuum TubingML8001VSML8001VS2020-08-28
00850724001209Vacuum TubingML8060VSML8060VS2020-08-27
10850724001107Vacuum TubingML8001VSML8001VS2020-08-28
00850724001902ML7 Eye Marker2100ML72100ML72020-08-28
00850011743997Wrench, Helical Drive, ML71350ML71350ML72020-08-27
10850724001206Vacuum TubingML8060VSML8060VS2020-08-27
00850724001681ML7 Microkeratome1700ML71700ML72020-08-27
00850724001780Footswitch, ML71800ML71800ML72020-08-27
00850724001803Handpiece, ML71400ML71400ML72020-08-27
00850724001810Sterilization Tray, ML71500ML71500ML72020-08-27
00850724001827Head, ML7, 100 Micron0100ML70100ML72020-08-27
00850724001834Head, ML7, 130 Micron0130ML70130ML72020-08-27
00850724001841Ring, ML7, 8.0mm1080ML71080ML72020-08-27
00850724001858Ring, ML7, 8.5mm1085ML71085ML72020-08-27
00850724001865Ring, ML7, 9.0mm1090ML71090ML72020-08-27
00850724001872Ring, ML7, 9.5mm1095ML71095ML72020-08-27
00850724001889Ring, ML7, 10.0mm1100ML71100ML72020-08-27
00850724001896Vacuum Handle, ML71300ML71300ML72020-08-27
00850724001049ML7040 (Minus 20)ML7040 (-20)ML7040 (-20)2020-08-14
00850724001070ML7061 (Plano)ML7061 (0)ML7061 (0)2020-08-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047926204Irrigation HandpieceA1 Medical GmbHKYG2026-05-29
04251047930003Aspiration HandpieceA1 Medical GmbHKYG2026-05-29
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
10810003224757NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224764NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224771NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224788NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224795NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224801NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224818NAMICROSPECIALITIES, INC.HNO2026-04-29
B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
00380650004529Wave Light FS200 EASYPACKAlcon Laboratories, Inc.HNO2025-11-20
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
B090MT20000MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08052276026378Passive Reservoir AKTIVE SRLKYG2024-01-11
08052276026385Active ReservoirAKTIVE SRLKYG2024-01-11
08052276027450Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11
08052276027276Dual Bore Cannula 20GAKTIVE SRLKYG2023-12-19
08052276027283Dual Bore Cannula 23GAKTIVE SRLKYG2023-12-19
08052276027306Dual Bore Cannula 25GAKTIVE SRLKYG2023-12-19
08052276027313Dual Bore Cannula 25G, 36mmAKTIVE SRLKYG2023-12-19
00805227602729Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2023-12-19
08717872013459Collection bag for Associate REF: 6279.ASD1 Cartridge.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.KYG2023-09-14
08717872002262Disposable Infusion Cannula, 6.0 mm.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.KYG2023-08-24
00840516135007Walcott Rx ProductsPsi/Eye-Ko, Inc.KYG2023-08-18
M170MT66730The Morgan mor-FLEX LensMortan Inc.KYG2023-08-09
00840516130477Anodyne SurgicalPsi/Eye-Ko, Inc.KYG2023-07-22