GUDID 00813250017557

TEW Cannula Nylon Screw

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Radio-frequency ablation system
Primary Device ID00813250017557
NIH Device Record Key0f3abcc9-6cd4-402d-9364-abd694fbe80e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTEW-CS
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813250017557 [Primary]

FDA Product Code

GXIPROBE, RADIOFREQUENCY LESION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813250017557]

Moist Heat or Steam Sterilization


[00813250017557]

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

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729966333 - Vercise™ Cartesia™ X2024-12-23 Directional Lead Kit, 16 Contact, 30cm
08714729966340 - Vercise™ Cartesia™ X2024-12-23 Directional Lead Kit, 16 Contact, 45cm
08714729966357 - Vercise™ Cartesia™ HX2024-12-23 Directional Lead Kit, 16 Contact, 30cm
08714729966364 - Vercise™ Cartesia™ HX2024-12-23 Directional Lead Kit, 16 Contact, 45cm
08714729966371 - NA2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm
08714729966388 - NA2024-12-23 Lead Extension Kit, 2x8 Contact, 95cm
08714729966395 - NA2024-12-23 16 Contact Lead Extension Kit, 55 cm
08714729966401 - NA2024-12-23 16 Contact Lead Extension Kit, 95 cm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.