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) (10)

Premarket Exempt

Yes No

Clear

RFS™ Screw - E302RFSS27249 Catalog Number : RFS-S2724

Device Description : RFS™ Screw 2.7 x 24 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35149 Catalog Number : RFS-S3514

Device Description : RFS™ Screw 3.5 x 14 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35169 Catalog Number : RFS-S3516

Device Description : RFS™ Screw 3.5 x 16 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35209 Catalog Number : RFS-S3520

Device Description : RFS™ Screw 3.5 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS3520L9 Catalog Number : RFS-S3520L

Device Description : RFS™ Screw LAG 3.5 x 20 mm, thread 8 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35249 Catalog Number : RFS-S3524

Device Description : RFS™ Screw 3.5 x 24 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35289 Catalog Number : RFS-S3528

Device Description : RFS™ Screw 3.5 x 28 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS3530L9 Catalog Number : RFS-S3530L

Device Description : RFS™ Screw LAG 3.5 x 30 mm, thread 14 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35329 Catalog Number : RFS-S3532

Device Description : RFS™ Screw 3.5 x 32 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RFS™ Screw - E302RFSS35369 Catalog Number : RFS-S3536

Device Description : RFS™ Screw 3.5 x 36 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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