SYNTEC SCIENTIFIC CORPORATION

Address:2, KUNG SAN ROAD, CHUAN SHING,CHANG HUA Changhua,TW

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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) (6) Instrument, Bending Or Contouring (HXP) (2) Plate, Fixation, Bone (HRS) (1)

Premarket Exempt

Yes No

Clear

Syntec-Taichung Non-sterile Bone Plate and Screw Implants - 04719864684672 Catalog Number :

Device Description : Straight Reconstruction Plate 3.5x 20Holes x L238mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Syntec Femoral Nail System - 04719873533466 Catalog Number :

Device Description : Syntec End Cap φ13 x L5mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Femoral Nail System - 04719873533473 Catalog Number :

Device Description : Syntec End Cap φ13 x L10mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec Femoral Nail System - 04719873533480 Catalog Number :

Device Description : Syntec End Cap φ13 x L15mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec End Cap - 04719873533497 Catalog Number :

Device Description : Syntec End Cap φ13 x L5mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec End Cap - 04719873533503 Catalog Number :

Device Description : Syntec End Cap φ13 x L10mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Syntec End Cap - 04719873533510 Catalog Number :

Device Description : Syntec End Cap φ13 x L15mm

Device Class : 2

Duns Number: 657692971

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

N/A - 04719875456992 Catalog Number : S329040

Device Description : Bending Iron for 2.7mm and 3.5mm plates 150mm

Device Class : 1

Duns Number: 657692971

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

N/A - 04719875457005 Catalog Number : S329050

Device Description : Bending Iron for 2.7mm and 3.5mm plates 150mm

Device Class : 1

Duns Number: 657692971

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

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