I.T.S. GmbH

Address:AUTAL 28,LASSNITZHOEHE Steiermark,AT

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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

No Yes

Clear

Epiphysis Screw - 09120034300851 Catalog Number : 38651-55

Device Description : Epiphysis Screw, D=6.5mm, L=55mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300868 Catalog Number : 38651-50

Device Description : Epiphysis Screw, D=6.5mm, L=50mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300875 Catalog Number : 38651-120

Device Description : Epiphysis Screw, D=6.5mm, L=120mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300882 Catalog Number : 38651-115

Device Description : Epiphysis Screw, D=6.5mm, L=115mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300899 Catalog Number : 38651-110

Device Description : Epiphysis Screw, D=6.5mm, L=110mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300905 Catalog Number : 38651-105

Device Description : Epiphysis Screw, D=6.5mm, L=105mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Epiphysis Screw - 09120034300912 Catalog Number : 38651-100

Device Description : Epiphysis Screw, D=6.5mm, L=100mm, 10mm Thread

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300929 Catalog Number : 37592-60

Device Description : Cancellous Screw, Locking, D=5.9mm, L=60mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300936 Catalog Number : 37592-56

Device Description : Cancellous Screw, Locking, D=5.9mm, L=56mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300943 Catalog Number : 37592-52

Device Description : Cancellous Screw, Locking, D=5.9mm, L=52mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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