SMV SCIENTIFIC LLC

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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

Instrument, Manual, Surgical, General Use (MDM) (3) Orthopedic Manual Surgical Instrument (LXH) (2) Screw, Fixation, Bone (HWC) (2) Tray, Surgical (LRP) (2) Tap, Bone (HWX) (1)

Premarket Exempt

No Yes

Clear

6.0 X 240MM TAP - 00816950029912 Catalog Number : 303-6024

Device Description : 6.0 X 240MM TAP

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

SLEEVE HANDLE - 00816950029929 Catalog Number : 303-0001

Device Description : SLEEVE HANDLE

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

AO QC T HANDLE - 00816950029936 Catalog Number : 110311

Device Description : AO QC T HANDLE

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

UNIVERSAL CHUCK T HANDLE - 00816950029943 Catalog Number : 110350

Device Description : UNIVERSAL CHUCK T HANDLE

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

SCHANZ PIN FASTENER OUTER CASE - 00816950029950 Catalog Number : 303-9001

Device Description : SCHANZ PIN FASTENER OUTER CASE

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

SCHANZ PIN FASTENER INSTRUMENT TRAY - 00816950029967 Catalog Number : 303-9002

Device Description : SCHANZ PIN FASTENER INSTRUMENT TRAY

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

OsteoCentric 2.70mm Guidewire, Drill Tip, 300mm CoCr - 00816950029981 Catalog Number : 2004-0022

Device Description : 2.70mm Guidewire, Drill Tip, 300mm Cobalt Chrome

Device Class : 1

Duns Number: 089645059

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

OsteoCentric 2.70mm Guidewire, Threaded Tip, 300mm CoCr - 00816950029998 Catalog Number : 2004-0023

Device Description : 2.70mm Guidewire, Threaded Tip, 300mm Cobalt Chrome

Device Class : 1

Duns Number: 089645059

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496011 Catalog Number : EX01-5028-12

Device Description : 2.8 mm Headless Compression Screw Fastener 12mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496028 Catalog Number : EX01-5028-14

Device Description : 2.8 mm Headless Compression Screw Fastener 14mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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