Precision Montage ™ MRI

GUDID 08714729907114

Implantable Pulse Generator and Charging Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID08714729907114
NIH Device Record Key38df4294-2bfd-4755-8dc1-5b645e12b96c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Montage ™ MRI
Version Model NumberSC-1210B
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729907114 [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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-20
Device Publish Date2016-05-03

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08714729966371 - NA2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm
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08714729966395 - NA2024-12-23 16 Contact Lead Extension Kit, 55 cm
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