Bioretec Oy

Address:Yrittajankulma 5,Tampere Pirkanmaa,FI

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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

Screw, Fixation, Bone (HWC) (5) Orthopedic Manual Surgical Instrument (LXH) (3) Instrument, Manual, Surgical, General Use (MDM) (2)

Premarket Exempt

No Yes

Clear

RFS Instrument - E302RFSPAR209 Catalog Number : RFS-PAR20

Device Description : RFS™ Reusable Pin Applicator 2.0mm

Device Class : 1

Duns Number: 368715301

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

RFS Instrument - E302RFSPAR279 Catalog Number : RFS-PAR27

Device Description : RFS™ Reusable Pin Applicator 2.7mm

Device Class : 1

Duns Number: 368715301

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

RFS Instrument - E302RFSPDR159 Catalog Number : RFS-PDR15

Device Description : RFS™ Pin Drill 1.5mm

Device Class : 1

Duns Number: 368715301

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RFS Instrument - E302RFSPDR209 Catalog Number : RFS-PDR20

Device Description : RFS™ Pin Drill 2.0mm

Device Class : 1

Duns Number: 368715301

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RFS Instrument - E302RFSPDR279 Catalog Number : RFS-PDR27

Device Description : RFS™ Pin Drill 2.7mm

Device Class : 1

Duns Number: 368715301

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS27129 Catalog Number : RFS-S2712

Device Description : RFS™ Screw 2.7 x 12 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS27149 Catalog Number : RFS-S2714

Device Description : RFS™ Screw 2.7 x 14 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS27169 Catalog Number : RFS-S2716

Device Description : RFS™ Screw 2.7 x 16 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS27189 Catalog Number : RFS-S2718

Device Description : RFS™ Screw 2.7 x 18 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS27209 Catalog Number : RFS-S2720

Device Description : RFS™ Screw 2.7 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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