Arbutus Medical
The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
1manufacturer
11catalogue numbers in this listing
Who Else Makes It
Registered in Hubei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Arbutus Medical, Inc, Canada |
|---|---|
| FDA product code | PYB |
| Device type | Minor Surgical Procedures Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-22 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 7 to 29 °C; Handling environment humidity 30 to 60 % RH |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | In distribution | ||
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | 6 | In distribution | |
| TrakPak | In distribution | ||
| Digit Revision SwiftKit | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merit Medical® | Merit Medical Systems, Inc. | 290 |
| Instrapac | Robinson Healthcare Limited | 65 |
| Punch Biopsy Set | Blink Medical Ltd | 2 |
| Biopsy Set | Blink Medical Ltd | 2 |
| Minor Ops Set | Blink Medical Ltd | 2 |
| Full Biopsy Set | Blink Medical Ltd | 2 |
| Atec | Hologic, Inc. | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Mammosite | Hologic, Inc. | 2 |
| Full Minor Op’s Set | Blink Medical Ltd | 1 |
| MoHs Set | Blink Medical Ltd | 1 |
| Invenio | GRI-Alleset, Inc. | 1 |
Showing 12 of 18. All products under Minor Surgical Procedures Tray
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.