DEVICE: Freelink™ (08714729907077)
Device Identifier (DI) Information
Freelink™
SC-5552-1
In Commercial Distribution
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5552-1
In Commercial Distribution
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Remote Control Kit
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62424 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit |
A portable, external, electrically-powered component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to be used by a patient to telemetrically control its function (on/off) for delivery of treatment cycles. The system is designed to deliver episodic electrical stimulation to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for the relief/treatment of acute and/or chronic intractable pain [e.g., chronic low back pain (CLBP)].
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P030017 | 235 |
P030017 | 357 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6f81d814-4edc-45bb-91ce-5d57d902bdce
August 20, 2024
4
May 03, 2016
August 20, 2024
4
May 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined