Arbutus Medical

GUDID 00844107000620

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.

Arbutus Medical Inc

General surgical procedure kit, medicated

• Primary Device ID: 00844107000620
• NIH Device Record Key: 956a2dcc-dc84-4a11-8806-366fb1b9b2b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arbutus Medical
• Version Model Number: TrakPak
• Company DUNS: 203296434
• Company Name: Arbutus Medical Inc
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844107000620 [Unit of Use]
GS1	00844107000637 [Primary]

FDA Product Code

• PYB: Minor Surgical Procedures Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-27
• Device Publish Date: 2021-10-19

On-Brand Devices [Arbutus Medical]

• 00844107000620: The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin s
• 00844107000590: Rechargeable battery-powered surgical power tool drill, non-sterile.
• 00844107000583: SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be implanted