WaveWriter Alpha™

GUDID 08714729994657

External Trial Stimulator

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, external
Primary Device ID08714729994657
NIH Device Record Key21f8b796-c801-48a7-99e8-877368fdc37f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveWriter Alpha™
Version Model NumberSC-5170
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
GS108714729994657 [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 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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