DEVICE: NA (08714729121411)

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Device Identifier (DI) Information
NA
SC-4100A
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729121411
GS1

1
824951958 *Terms of Use
OR Cable and Extension
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
37307 Deep brain electrical stimulation system
An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.
Active true
63365 Implantable electrical stimulation system intraoperative test lead
A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MHY Stimulator, electrical, implanted, for parkinsonian tremor
PJS Stimulator, electrical, implanted, for essential tremor
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
NHL STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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 000
P030017 270
P030017 357
P030017 363
P150031 000
P150031 028
P150031 040
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Sterilization
Yes
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

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Size Type Text
No Device Sizes
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Device Record Status
dae50207-ee4d-4ba3-bd85-ca449ce0542d
March 14, 2024
6
November 09, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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
No
Yes
No
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Customer Contact

[?]
No Customer Contact currently defined
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