FDA.reportPublic FDA data

Handpiece, ML7

Primary DI
00850724001803
Brand
Handpiece, ML7
Company
MED LOGICS INC
Model
1400ML7
Catalog number
1400ML7
Device description
Handpiece for use with the ML7 Microkeratome
Published
2020-08-27
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
HNOKeratome, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850724001803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850724001803008507240018038507240018030850724001803

GMDN Terms#

Term, Definition table
TermDefinition
MicrokeratomeAn electrically-powered ophthalmic surgical instrument intended to be used to create a corneal pocket for the insertion of a corneal implant or to create a flap to prepare the cornea for laser vision correction. It typically consists of a suction ring, an applanator for flattening of the cornea and a mounted blade to create a corneal pocket or a flap. This device is not intended to be used to cut or shave tissue sections from the cornea.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
075390489
Device count
1
Serial number
true
Manufacturing date on label
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
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
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