- Physicians Office Resource

LEAD 3587A25 RESUME II BLU TRQE WRN 25CM
RESUME ® II - 3587A25

Device Description

An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

57.00
-34.00

Storage Environment Temperature - Degrees Fahrenheit

135.00
-30.00

Device Sizes

Length: 25.0 Centimeter

Length: 25.0 Centimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: GZF

Device Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 882.5870

Third Party Flag: N

Medical Specialty: NE

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 Identifiers

Device Id: 00643169187948

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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