FDA.reportPublic FDA data

ML7 Eye Marker

Primary DI
00850724001902
Brand
ML7 Eye Marker
Company
MED LOGICS INC
Model
2100ML7
Catalog number
2100ML7
Device description
Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring
Published
2020-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850724001902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850724001902008507240019028507240019020850724001902

GMDN Terms#

Term, Definition table
TermDefinition
Eyeball fixation instrument, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
075390489
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing 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
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
00850724001148ML7040 (Plano)ML7040 (0)ML7040 (0)2020-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
00757770714643Bausch + LombBausch & Lomb IncorporatedHMR2026-05-11
00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144336KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144343KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144367KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04