FDA.reportPublic FDA data

ML7003

Primary DI
00850724001018
Brand
ML7003
Company
MED LOGICS INC
Model
ML7003
Catalog number
ML7003
Device description
Sterile Disposable microkeratome blade, for use on the ACS Microkeratome
Published
2020-08-12
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962661000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962661000ML MICROKERATOME BLADEMed-Logics, Inc.1996-12-09HNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850724001015PackageGS110In Commercial Distribution
00850724001018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085072400101510850724001015
00850724001018008507240010188507240010180850724001018

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
949-582-3891justin.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
00194613046149MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2024-08-15
00840516141183Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2024-08-15
08052276012432Irrigating Cystotome Ang.45° 27Gx16mm AKTIVE SRLHNY2023-12-19
08052276012937Irrigating Cystotome Formed 27G x 16mmAKTIVE SRLHNY2023-12-19
08052276012968Irrigating Cystotome Ang.45° 25G x16 mm AKTIVE SRLHNY2023-12-19
00840516105345Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-10-10
00840516116600Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116617Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116624Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116631Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116648Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116655Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116662Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116679Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116686Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116693Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116709Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116716Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116754Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116761Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116778Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116785Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116792Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116808Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116815Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116822Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116839Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116846Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116853Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116860Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28