BIOPRO, INC.

Address:2929 Lapeer Rd,PORT HURON,MI,48060,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

Pin, Fixation, Smooth (HTY) (5) Orthopedic Manual Surgical Instrument (LXH) (4) Impactor (HWA) (1)

Premarket Exempt

No Yes

Clear

K-WIRE 1.1X150MM DBL TROCAR RAW - M20922827 Catalog Number :

Device Class : 2

Duns Number: 618749857

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-WIRE STERILE 1.4MMX300MM DBL TROCAR - M20922828 Catalog Number :

Device Class : 2

Duns Number: 618749857

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-WIRE 1.4X300MM DBL TROCAR RAW - M20922829 Catalog Number :

Device Class : 2

Duns Number: 618749857

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-WIRE STERILE 0.9MMX70MM SNG TROCAR - M20922830 Catalog Number :

Device Class : 2

Duns Number: 618749857

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-WIRE 0.9X70MM SNG TROCAR Non Sterile - M20922831 Catalog Number :

Device Class : 2

Duns Number: 618749857

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Shotel Nail System - M20922839 Catalog Number :

Device Description : COMPRESSION SLEEVE, LEFT-CF

Device Class : 1

Duns Number: 618749857

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Subtalar Gen 2 QR Handle 3/16 Black - M20922854 Catalog Number :

Device Class : 1

Duns Number: 618749857

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

BioPro - M20922860 Catalog Number :

Device Description : ONE PIECE THUMB STEM RASP 7.5MM

Device Class : 1

Duns Number: 618749857

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

BioPro - M20922861 Catalog Number :

Device Description : ONE PIECE THUMB STEM RASP 8.5MM

Device Class : 1

Duns Number: 618749857

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

BioPro - M20922862 Catalog Number :

Device Description : ONE PIECE THUMB STEM RASP 10.0MM

Device Class : 1

Duns Number: 618749857

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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