NM-7153-11A

GUDID 08714729897811

Clinician Programmer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable spinal cord electrical stimulation system programmer
Primary Device ID08714729897811
NIH Device Record Key9f91b120-e7b6-4b19-ae1e-ea027477feea
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-7153-11A
Catalog NumberNM-7153-11A
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 Numbertrue
Manufacturing Datefalse
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
GS108714729897811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-21
Device Publish Date2015-09-04

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729897804 - NA2024-08-21 Installer for BN3.1
08714729897811 - NA2024-08-21Clinician Programmer
08714729897811 - NA2024-08-21 Clinician Programmer
08714729897835 - Precision Novi™2024-08-21 Implantable Pulse Generator Kit
08714729897873 - NA2024-08-21 Clinican Programmer (Refurbished)
08714729904816 - Avista™ MRI2024-08-21 56cm 8 Contact Lead Kit
08714729904823 - Avista™ MRI2024-08-21 74cm 8 Contact Lead Kit
08714729905387 - Freelink™2024-08-21 Remote Control
08714729905486 - Freelink™2024-08-21 Remote Control Kit

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