AccessGUDID - DEVICE: NA (00191506023577)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: DB-3128-55B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M365DB312855B0
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 00191506023577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: 55cm, 2x8 Contact Lead Extension Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37307	Deep brain electrical stimulation system	An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PJS	Stimulator, electrical, implanted, for essential tremor
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms
MHY	Stimulator, electrical, implanted, for parkinsonian tremor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150031	049
P150031	064

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 55 Centimeter

Device Record Status

Public Device Record Key: 2274af90-9d90-46a9-8b0d-0b0c9c5e83e5
Public Version Date: December 13, 2024
Public Version Number: 2
DI Record Publish Date: October 31, 2022