FDA UDI
In Commercial Distribution
🇺🇸 United States
Arbutus Medical
DI: 00844107000590
·
Model: SteriTrak Drill
·
Arbutus Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arbutus Medical
- Primary DI
- 00844107000590
- Version / Model
- SteriTrak Drill
- Company Name
- Arbutus Medical Inc
- Labeler DUNS
- 203296434
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-19
- Public Version
- 1
- Public Version Date
- 2021-10-27
- Public Version Status
- New
- Public Device Record Key
- b9ebdd59-edf3-4e64-8e25-31d267b573ee
Device Description
Rechargeable battery-powered surgical power tool drill, non-sterile.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41781 | Surgical power tool system handpiece, wire-driving, rechargeable battery-powered | A 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844107000590 | GS1 |