FDA.reportPublic FDA data

Arbutus Medical

Primary DI
00844107000637
Brand
Arbutus Medical
Company
Arbutus Medical Inc
Model
TrakPak
Device 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.
Published
2021-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYBMinor Surgical Procedures Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844107000637PrimaryGS10
00844107000620Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844107000637008441070006378441070006370844107000637
00844107000620008441070006208441070006200844107000620

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA 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.

Regulatory Flags#

DUNS number
203296434
Device count
6
Premarket exempt
true
Kit
true
Combination product
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
00844107000590Arbutus MedicalSteriTrak Drill2021-10-19
00844107000620Arbutus MedicalTrakPak2021-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
M7526821425R10STRADIS HEALTHCARESTRADIS MEDICAL, LLCPYB2022-12-22
10197106029916CARDINAL HEALTHCardinal Health 200, LLCPYB2022-11-18
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
H65857030875Henry ScheinHENRY SCHEIN, INC.PYB2022-05-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31
00884450055144PAL™Merit Medical Systems, Inc.PYB2018-09-17
00884450166062Merit Medical®Merit Medical Systems, Inc.PYB2018-09-17
00884450049556Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049570Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049587Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049594Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049617Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053799Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053805Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053836Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055120Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055137Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450143865Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450144558Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14