Ulrich GmbH & Co. KG

Address:BUCHBRUNNENWEG 12,ULM Baden-Wurttemberg,DE

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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

Injector, contrast medium, automatic (IZQ) (5) APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (2) Orthosis, cervical pedicle screw spinal fixation (NKG) (2) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE (MQP) (2) Iodinated contrast media transfer tubing set (PQH) (1)

Premarket Exempt

Clear

VBR Omni™ vertebral body replacement - 04052536179275 Catalog Number : CS 2250-30-7222

Device Description : VBR Omni, Ø 30mm, height 72-131 mm, angle 22°

Device Class : 2

Duns Number: 315494757

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

VBR Omni™ vertebral body replacement - 04052536179282 Catalog Number : CS 2250-30-728

Device Description : VBR Omni, Ø 30mm, height 72-131 mm, angle 8°

Device Class : 2

Duns Number: 315494757

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

N/A - 04052536179923 Catalog Number : XD 2037

Device Description : Patient tubing 150 cm for Pump tubing - flex

Device Class :

Duns Number: 315494757

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

N/A - 04052536180400 Catalog Number : XD 2042

Device Description : Patient tubing 250 cm for Pump tubing - flex

Device Class :

Duns Number: 315494757

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

N/A - 04052536180424 Catalog Number : XD 2047

Device Description : Patient tubing 320 cm for Pump tubing - flex

Device Class :

Duns Number: 315494757

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

N/A - 04052536181216 Catalog Number : XD 8132

Device Description : Spike for CT (CM/NaCl) for ulrichINJECT CT injectors

Device Class :

Duns Number: 315494757

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

N/A - 04052536184088 Catalog Number : XD 40101

Device Description : ulrich Transfer Set, 20 in for USA only: For use with Omnipaque Imaging Bulk Package

Device Class : 2

Duns Number: 315494757

Premarket Exempt : No

Product Code : PQH

Prescription Use : Yes

Device Count : 1

N/A - 04052536184514 Catalog Number : XD 8002

Device Description : Pump tubing - flex for ulrichINJECT CT injectors

Device Class :

Duns Number: 315494757

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

NEON 3 - 04052536192526 Catalog Number : CS 3913-55-06

Device Description : Occipital screw, Ø 5.5 mm, length 6 mm, self-tapping

Device Class : 2

Duns Number: 315494757

Premarket Exempt : No

Product Code : KWP, NKG

Prescription Use : Yes

Device Count : 1

NEON 3 - 04052536192533 Catalog Number : CS 3913-55-08

Device Description : Occipital screw, Ø 5.5 mm, length 8 mm, self-tapping

Device Class : 2

Duns Number: 315494757

Premarket Exempt : No

Product Code : NKG, KWP

Prescription Use : Yes

Device Count : 1

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