DEVICE: NA (08714729996712)

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Device Record History
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Device Identifier (DI) Information
NA
SC-6386
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729996712
GS1

1
824951958 *Terms of Use
Pairing Magnet
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Device Characteristics
Labeling does not contain MRI Safety Information
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?
57996 Active implantable device control magnet
A hand-operated, non-sterile, magnetic device designed to be used by a patient and a healthcare professional to switch an active implantable device (e.g., pulse generator, implantable cardiac monitor) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implant and turned as prescribed by the manufacturer. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
LGW Stimulator, spinal-cord, totally implanted for pain relief
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030017 338
P030017 357
P030017 363
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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

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Size Type Text
No Device Sizes
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Device Record Status
e910d151-45ef-47af-99fa-ae0b5a52633e
August 21, 2024
3
December 28, 2020
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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

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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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