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

Wrench (HXC) (4) Screwdriver, Surgical (LRZ) (3) Bit, Drill (HTW) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Spiral Drill - 09120034300578 Catalog Number : 61253-180

Device Description : Spiral Drill, D=2.5mm, L=180mm, AO Connector

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Spiral Drill - 09120034300585 Catalog Number : 61253-110

Device Description : Spiral Drill, D=2.5mm, L=110mm, AO Connector

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Socket Spanner - 09120034300608 Catalog Number : 56702-240

Device Description : Socket Spanner, WS 7, L=240mm

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : No

Device Count : 1

Screw Driver - 09120034300639 Catalog Number : 56352-SH

Device Description : Screw Driver, WS 3.5, Conic, Self Holding

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : LRZ

Prescription Use : No

Device Count : 1

Screwdriver - 09120034300646 Catalog Number : 56253-170

Device Description : Screw Driver, Handle 25mm, WS 2.5, L=170mm, Can. 1.7mm

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : LRZ

Prescription Use : No

Device Count : 1

Socket Wrench - 09120034300653 Catalog Number : 561002-250

Device Description : Socket Wrench, WS 10, L=250mm

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : No

Device Count : 1

Socket Spanner - 09120034300660 Catalog Number : 561002-200

Device Description : Socket Spanner, WS 10, L=200mm

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : No

Device Count : 1

Self Holding Sleeve - 09120034300677 Catalog Number : 56095-70-2

Device Description : Self Holding Sleeve, Screwdriver, Torque 9

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Screw Driver - 09120034300684 Catalog Number : 56095-70

Device Description : Screw Driver, Torque, T9x70

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : LRZ

Prescription Use : No

Device Count : 1

Socket Spanner - 09120034300691 Catalog Number : 560701-350

Device Description : Socket Spanner with Handle, SW 7, L=350mm

Device Class : 1

Duns Number: 303456917

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : No

Device Count : 1

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