FDA.reportPublic FDA data

ML7040 (Minus 20)

Primary DI
00850724001049
Brand
ML7040 (Minus 20)
Company
MED LOGICS INC
Model
ML7040 (-20)
Catalog number
ML7040 (-20)
Device description
Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome
Published
2020-08-14
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002515000MEDLOGICS ML 4000, MODEL 4000Med-Logics, Inc.2001-02-22HNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850724001046PackageGS110In Commercial Distribution
00850724001049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085072400104610850724001046
00850724001049008507240010498507240010490850724001049

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
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
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
00380650004529Wave Light FS200 EASYPACKAlcon Laboratories, Inc.HNO2025-11-20
03700483603121MORIAMORIA SAHNO2024-05-07
03700483603145MORIAMORIA SAHNO2024-05-07
03700483603169MORIAMORIA SAHNO2024-05-07
03700483603183MORIAMORIA SAHNO2024-05-07
03700483603206MORIAMORIA SAHNO2024-05-07
03700483603220MORIAMORIA SAHNO2024-05-07
03700483603244MORIAMORIA SAHNO2024-05-07
03700483603374MORIAMORIA SAHNO2024-05-07
03700483603398MORIAMORIA SAHNO2024-05-07
03700483603930MORIAMORIA SAHNO2024-05-07
03700483603954MORIAMORIA SAHNO2024-05-07
03700483603138MORIAMORIA SAHNO2024-05-07
03700483603152MORIAMORIA SAHNO2024-05-07
03700483603176MORIAMORIA SAHNO2024-05-07
03700483603190MORIAMORIA SAHNO2024-05-07
03700483603213MORIAMORIA SAHNO2024-05-07
03700483603237MORIAMORIA SAHNO2024-05-07
03700483603251MORIAMORIA SAHNO2024-05-07
03700483603381MORIAMORIA SAHNO2024-05-07
03700483603404MORIAMORIA SAHNO2024-05-07
03700483603947MORIAMORIA SAHNO2024-05-07
03700483603961MORIAMORIA SAHNO2024-05-07