Arbutus Medical Inc

Address:2520 Columbia St,Vancouver British Columbia,CA

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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

Component, Traction, Invasive (JEC) (1) Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (1) Minor Surgical Procedures Tray (PYB) (1)

Premarket Exempt

No Yes

Clear

Arbutus Medical - 00844107000583 Catalog Number :

Device Description : SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended

Device Class :

Duns Number: 203296434

Premarket Exempt : No

Product Code : JEC

Prescription Use : Yes

Device Count : 10

Arbutus Medical - 00844107000590 Catalog Number :

Device Description : Rechargeable battery-powered surgical power tool drill, non-sterile.

Device Class : 1

Duns Number: 203296434

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

Arbutus Medical - 00844107000637 Catalog Number :

Device Description : The TrakPak surgical kit is intended to provide general medical devices and an a

Device Class : 1

Duns Number: 203296434

Premarket Exempt : Yes

Product Code : PYB

Prescription Use : Yes

Device Count : 6

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