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

Template (HWT) (9) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

Spike - 09120034300196 Catalog Number : 70301-7

Device Description : Spike, WS 7, PRS Set

Device Class : 2

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : No

Device Count : 1

Template - 09120034300233 Catalog Number : 67195-8

Device Description : Template, PRS, 8-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300240 Catalog Number : 67195-7

Device Description : Template, PRS, 7-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300257 Catalog Number : 67195-6

Device Description : Template, PRS, 6-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300264 Catalog Number : 67195-5

Device Description : Template, PRS, 5-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300271 Catalog Number : 67195-4

Device Description : Template, PRS, 4-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300288 Catalog Number : 67195-16

Device Description : Template, PRS, 16-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300295 Catalog Number : 67195-14

Device Description : Template, PRS, 14-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300301 Catalog Number : 67195-12

Device Description : Template, PRS, 12-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Template - 09120034300318 Catalog Number : 67195-10

Device Description : Template, PRS, 10-Hole, Curved, R108

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

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