GUDID 08714729994923

Clinician Programmer (Refurbished)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer
Primary Device ID08714729994923
NIH Device Record Keyad7a180b-b343-4231-89e3-f33273d6fdfb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNM-7161-R-W10
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
GS108714729994923 [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 Date2020-11-06
Device Publish Date2020-10-29

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

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