FDA.reportPublic FDA data

Arbutus Medical

Primary DI
00844107000590
Brand
Arbutus Medical
Company
Arbutus Medical Inc
Model
SteriTrak Drill
Device description
Rechargeable battery-powered surgical power tool drill, non-sterile.
Published
2021-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844107000590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844107000590008441070005908441070005900844107000590

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, wire-driving, rechargeable battery-poweredA battery-powered, drill-like, machine intended to be used for the sole purpose of driving in orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different widths that are pointed for self-drilling), into bone for the restoration of bones. This device will typically have a special gripping collet for rapid repositioning of the hold on the wire as it is fed into the bone. A rechargeable battery pack is attached to this device to provide the low-voltage electrical power. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203296434
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844107000736Arbutus MedicalTrakPak2026-04-28
00844107000750Arbutus MedicalTrakPak2026-04-28
00844107000781Arbutus MedicalTrakPak2026-04-28
00844107000804QuikBow QuikBow2026-04-28
00844107000828Arbutus MedicalDigit Revision SwiftKit 2026-04-28
00844107000583Arbutus MedicalSteriTrak2021-10-19
00844107000637Arbutus MedicalTrakPak2021-10-19
00844107000620Arbutus MedicalTrakPak2021-10-19

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Primary DI, Brand, Company table
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