MED LOGICS INC

Address:1627 Enterprise St,Athens,TX,75751,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Keratome, Ac-Powered (HNO) (9) Device, Irrigation, Ocular Surgery (KYG) (1)

Premarket Exempt

No Yes

Clear

Vacuum Tubing - 00850724001100 Catalog Number : ML8001VS

Device Description : Disposable Microkeratome Vacuum Tubing

Device Class : 1

Duns Number: 075390489

Premarket Exempt : No

Product Code : KYG

Prescription Use : Yes

Device Count : 1

ML7020 (Minus 30) - 00850724001117 Catalog Number : ML7020 (-30)

Device Description : Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7020 (Plus 10) - 00850724001124 Catalog Number : ML7020 (+10)

Device Description : Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, Sample

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7030 (Plano) - 00850724001131 Catalog Number : ML7030 (0)

Device Description : Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome S Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : No

Device Count : 1

ML7040 (Plano) - 00850724001148 Catalog Number : ML7040 (0)

Device Description : Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome

Device Class : 1

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7050 (Minus 10) - 00850724001155 Catalog Number : ML7050 (-10)

Device Description : Sterile disposable microkeratome blade, for use on the Moria® M2 Microkeratome, Sample

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7061 (Minus 30) - 00850724001162 Catalog Number : ML7061 (-30)

Device Description : Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head

Device Class : 1

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7061 (Plus 10) - 00850724001179 Catalog Number : ML7061 (+10)

Device Description : Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head

Device Class : 1

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7090 (Plus 20) - 00850724001186 Catalog Number : ML7090 (+20)

Device Description : Sterile disposable microkeratome blade, for use on the Amadeus® Microkeratome, Sample

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

ML7100 (Plano) - 00850724001193 Catalog Number : ML7100 (0)

Device Description : Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkera Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample

Device Class :

Duns Number: 075390489

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

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