Device
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...
Manufacturer
Arbutus Medical Inc
Arbutus Medical Inc
Model: TrakPak
DI: 00844107000736
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2409d503-423d-4512-b43e-85472ac9d7c9
Distribution Status:
In Commercial Distribution
DUNS Number:
203296434
Device Count:
6
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00844107000729
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00844107000736
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44057
Name: General surgical procedure kit, medicated
Definition:
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
FDA Product Codes
PYB
Minor Surgical Procedures Tray