Synthes GmbH

Address:Industriestrasse 28,Selzach Solothurn,CH

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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

EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR (MQN) (10) Cranial Distraction System (PBJ) (8)

Premarket Exempt

No Yes

Clear

NA - 20887587071869 Catalog Number : 0431582405

Device Description : 2.0MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : PBJ, MQN

Prescription Use : Yes

Device Count : 5

NA - 20887587071876 Catalog Number : 0431582605

Device Description : 2.0MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/6MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN, PBJ

Prescription Use : Yes

Device Count : 5

NA - 20887587071883 Catalog Number : 0431582805

Device Description : 2.0MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/8MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN, PBJ

Prescription Use : Yes

Device Count : 5

NA - 20887587071890 Catalog Number : 0431583005

Device Description : 2.0MM TI RAISED HEAD SCREW SELF-TAPPING/PLUSDRIVE®/10MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN, PBJ

Prescription Use : Yes

Device Count : 5

NA - 20887587071906 Catalog Number : 0431583205

Device Description : 2.0MM TI RAISED HEAD SCREW SELF-TAPPING/PLUSDRIVE®/12MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : PBJ, MQN

Prescription Use : Yes

Device Count : 5

NA - 20887587071982 Catalog Number : 0431575205

Device Description : 1.3MM TI RAISED HEAD SCREW SELF-TAPPING/PLUSDRIVE®/12MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN

Prescription Use : Yes

Device Count : 5

NA - 20887587072026 Catalog Number : 0431578405

Device Description : 1.5MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN, PBJ

Prescription Use : Yes

Device Count : 5

NA - 20887587072033 Catalog Number : 0431578605

Device Description : 1.5MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/6MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : PBJ, MQN

Prescription Use : Yes

Device Count : 5

NA - 20887587072040 Catalog Number : 0431572405

Device Description : 1.2MM TI RAISED HEAD EMERG SCR PLUSDRIVE®/4MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : MQN

Prescription Use : Yes

Device Count : 5

NA - 20887587072057 Catalog Number : 0431578805

Device Description : 1.5MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/8MM

Device Class :

Duns Number: 486711679

Premarket Exempt : No

Product Code : PBJ, MQN

Prescription Use : Yes

Device Count : 5

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