DEVICE: Precision™ (08714729893288)

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Device Record History
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Device Identifier (DI) Information
Precision™
SC-9208-55
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729893288
GS1

1
824951958 *Terms of Use
S8 Adapter, 55cm
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Device Characteristics
MR Conditional
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?
65308 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension
An implantable device intended to extend the electrical connection between a spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator and a lead(s). It typically includes small connectors to enable attachment to the lead(s) and pulse generator, and a length of insulated wire; the lead(s) and pulse generator are not included.
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 210
P030017 314
P030017 357
P030017 363
P030017 365
No CLOSE

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

[?]
Size Type Text
Device Size Text, specify: 55 cm Length
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Device Record Status
3219af8b-b782-46bf-8408-64634ad93c93
September 24, 2024
5
December 14, 2015
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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