AccessGUDID - DEVICE: Bionic Navigator ™ (08714729972518)

GUDID

Device Identifier (DI) Information

Brand Name: Bionic Navigator ™
Version or Model: DB-7101-204
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 08714729972518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: 2.04 Installer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150031	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 0947b6b0-95f3-4327-a467-1ac6f9f1d597
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2017