WaveWriter Alpha™

GUDID 08714729985099

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, implantable
Primary Device ID08714729985099
NIH Device Record Keyaf605281-ffd6-437c-9615-68a2d6f0621e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveWriter Alpha™
Version Model NumberSC-1232
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS108714729985099 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-05
Device Publish Date2020-12-28

On-Brand Devices [WaveWriter Alpha™]

08714729995241Patient Trial Kit
08714729994657External Trial Stimulator
08714729985099Implantable Pulse Generator Kit

Trademark Results [WaveWriter Alpha]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WAVEWRITER ALPHA
WAVEWRITER ALPHA
88456779 not registered Live/Pending
Boston Scientific Neuromodulation Corporation
2019-06-03

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