FDA.reportPublic FDA data

ML7020 (Plano)

Primary DI
00850724001025
Brand
ML7020 (Plano)
Company
MED LOGICS INC
Model
ML7020 (0)
Catalog number
ML7020 (0)
Device description
Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, 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
K022716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022716000MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLBMed-Logics, Inc.2002-10-11HNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850724001022PackageGS110In Commercial Distribution
00850724001025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085072400102210850724001022
00850724001025008507240010258507240010250850724001025

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

Other Devices Sharing Product Codes#

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