DEVICE: Freelink™ (08714729907077)

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Device Record History
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Device Identifier (DI) Information
Freelink™
SC-5552-1
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729907077
GS1

1
824951958 *Terms of Use
Remote Control Kit
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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
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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
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030017 235
P030017 357
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6f81d814-4edc-45bb-91ce-5d57d902bdce
August 20, 2024
4
May 03, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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