WaveWriter Alpha™ 16

GUDID 08714729985082

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Analgesic spinal cord electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID08714729985082
NIH Device Record Keybb317a82-d773-453e-850c-905dac1fef62
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveWriter Alpha™ 16
Version Model NumberSC-1216
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
GS108714729985082 [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

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729121688 - Precision ™2024-03-25 Adhesive Kit
08714729121435 - Precision™2024-03-19 Hex Wrench
08714729121442 - NA2024-03-19 10cm (4 Inch) Insertion Needle
08714729121459 - NA2024-03-19 13cm (5 Inch) Insertion Needle
08714729121497 - NA2024-03-19 Stylet Kit with Stylet Cap 30cm
08714729121503 - NA2024-03-19 Stylet Kit with Stylet Cap 50cm
08714729121510 - NA2024-03-19 Stylet Kit with Stylet Cap 70cm
08714729121558 - NA2024-03-19 Enhanced Steering Kit with Stylet Cap 30cm

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.