TRICE MEDICAL, INC.

TRICE MEDICAL, INC.

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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

Arthroscope (HRX) (5) Kit, Surgical Instrument, Disposable (KDD) (2) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2) Probe (HXB) (1)

Premarket Exempt

No Yes

Clear

mi-ultra LR - 00857356008002 Catalog Number :

Device Description : Ultrasound Linear Transducer

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

mi-ultra CX - 00857356008019 Catalog Number :

Device Description : Ultrasound Convex Transducer

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

mi-tablet 2 - 00857356008064 Catalog Number :

Device Description : Tablet for use as part of the mi-eye 2 System.

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

mi-eye 2 95mm - 00861578000331 Catalog Number :

Device Description : mi-eye 2 probe 95mm length for use with Trice Tablet 2

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Trice Tablet 2 - 00861578000348 Catalog Number :

Device Description : Tablet for use with mi-eye 2 probe

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Trice Tablet 2 - 00861578000355 Catalog Number :

Device Description : Tablet for use with mi-eye 2 probe. Reburbished.

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

mi-eye 2 160mm - 00861578000362 Catalog Number :

Device Description : mi-eye 2 probe 160mm length for use with Trice Tablet 2

Device Class : 2

Duns Number: 009452895

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

mi-eye Procedure Kit - 00861578000379 Catalog Number :

Device Description : medical supplies kit for use during mi-eye procedures. contains off-the-shelf m medical supplies kit for use during mi-eye procedures. contains off-the-shelf medical supplies.

Device Class : 1

Duns Number: 009452895

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

mi-probe - 00861578000386 Catalog Number : T900-015

Device Description : mi-probe. surigcal instrument for soft tissue manipulation during mi-eye procedure

Device Class : 1

Duns Number: 009452895

Premarket Exempt : Yes

Product Code : HXB

Prescription Use : Yes

Device Count : 1

mi-eye Procedure Kit 5 pack - 10861578000376 Catalog Number :

Device Description : pack of 5 T900-001

Device Class : 1

Duns Number: 009452895

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : Yes

Device Count : 1

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