MICROSPECIALITIES, INC.

Address:430 Smith St,Middletown,CT,06457,US

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Filters

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) (8) Sponge, Ophthalmic (HOZ) (2)

Premarket Exempt

No Yes

Clear

NA - 10810003221138 Catalog Number : MK-101101-20

Device Description : MicroKeratome Blades, Laser Calibrated XP minus 20. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP minus 20. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221145 Catalog Number : MK-101101-30

Device Description : MicroKeratome Blades, Laser Calibrated XP minus 30. Have the ultimate control o MicroKeratome Blades, Laser Calibrated XP minus 30. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221152 Catalog Number : MK-101101-40

Device Description : MicroKeratome Blades, Laser Calibrated XP minus 40. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP minus 40. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221169 Catalog Number : MK-101101+10

Device Description : MicroKeratome Blades, Laser Calibrated XP plus 10. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP plus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221176 Catalog Number : MK-101101+20

Device Description : MicroKeratome Blades, Laser Calibrated XP plus 20. Have the ultimate control of MicroKeratome Blades, Laser Calibrated XP plus 20. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221336 Catalog Number : MK-200200

Device Description : MicroKeratome Blades, MORIA LSK Compatible. Each blade is laser inspected and ca MicroKeratome Blades, MORIA LSK Compatible. Each blade is laser inspected and calibrated. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

NA - 10810003221527 Catalog Number : MK-300300

Device Description : MicroKeratome Blades, BD K-3000, K-4000 Compatible. Each blade is laser inspect MicroKeratome Blades, BD K-3000, K-4000 Compatible. Each blade is laser inspected and calibrated. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

Pro-Paks - 10810003221923 Catalog Number : MK-500-6mm

Device Description : Corneal Light Shield, 20/bx. Our effective synthetic PVA shields are highly abso Corneal Light Shield, 20/bx. Our effective synthetic PVA shields are highly absorbent allowing aqueous solutions to be wicked up quickly.

Device Class :

Duns Number: 013469890

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

Pro-Paks - 10810003221930 Catalog Number : MK-500-8mm

Device Class :

Duns Number: 013469890

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : Yes

Device Count : 1

NA - 10810003221954 Catalog Number : MK-500500

Device Description : MicroKeratome Blades, ACS/ALK. Each blade is laser inspected and calibrated. 10/bx

Device Class : 1

Duns Number: 013469890

Premarket Exempt : No

Product Code : HNO

Prescription Use : Yes

Device Count : 1

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