GUDID 00813250017519

Nitinol TC Electrode, 15cm, 3m Cable

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Radio-frequency ablation system
Primary Device ID00813250017519
NIH Device Record Key9449fcf3-6d9a-46d7-a268-08b8dbfc0fcc
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTCN-15-3M
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100813250017519 [Primary]

FDA Product Code

GXDGENERATOR, LESION, RADIOFREQUENCY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


[00813250017519]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-08
Device Publish Date2017-08-21

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