ACCY 3550
N/A - 3550-06
Device Description
A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MHY
Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Code: LGW
Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Code: NHL
Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Device Class: 3
Physical State: N/A
Definition: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
Submission Type ID: 2
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Code: QRB
Device Name: Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
Device Class: 3
Physical State: Pulse generator, leads, accessories, software
Definition: To relieve pain in patients with diabetic neuropathy
Submission Type ID: 2
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: An implantable pulse generator provides electrical stimulation to the spinal cord using implanted leads, resulting in pain relief
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Spinal cord
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00643169953581
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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