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

Cancellous Screw, Locking - 09120034300950 Catalog Number : 37592-48

Device Description : Cancellous Screw, Locking, D=5.9mm, L=48mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300967 Catalog Number : 37592-44

Device Description : Cancellous Screw, Locking, D=5.9mm, L=44mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300974 Catalog Number : 37592-40

Device Description : Cancellous Screw, Locking, D=5.9mm, L=40mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300981 Catalog Number : 37592-36

Device Description : Cancellous Screw, Locking, D=5.9mm, L=36mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034300998 Catalog Number : 37592-32

Device Description : Cancellous Screw, Locking, D=5.9mm, L=32mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034301001 Catalog Number : 37592-28

Device Description : Cancellous Screw, Locking, D=5.9mm, L=28mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034301018 Catalog Number : 37592-24

Device Description : Cancellous Screw, Locking, D=5.9mm, L=24mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034301025 Catalog Number : 37592-20

Device Description : Cancellous Screw, Locking, D=5.9mm, L=20mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034301179 Catalog Number : 37422-60

Device Description : Cancellous Screw, Locking, D=4.2mm, L=60mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Cancellous Screw, Locking - 09120034301186 Catalog Number : 37422-55

Device Description : Cancellous Screw, Locking, D=4.2mm, L=55mm

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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