DEVICE: NA (00813250012118)

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Device Record History
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Device Identifier (DI) Information
NA
RFK-C15518S
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
00813250012118
GS1

1
824951958 *Terms of Use
Cannula, 15cm, 5mm tip, 18G Sharp Curved
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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?
57972 Radio-frequency ablation system
An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GXI PROBE, RADIOFREQUENCY LESION
GXD GENERATOR, LESION, RADIOFREQUENCY
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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: 5 mm Length
Device Size Text, specify: 15 cm Length
Device Size Text, specify: 18 ga Diameter
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Device Record Status
8482b5d9-5887-40dc-b9e0-b1ec1e640430
October 08, 2018
3
June 29, 2017
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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
00813250010824 10 00813250012118 In Commercial Distribution
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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