ENS 97725 WIRELESS INTELLIS US EMAN

ENS 97725 WIRELESS INTELLIS US EMAN
N/A - 97725

An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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 Id: 00763000689469

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