AccessGUDID - DEVICE: ACTIVA® Therapy (00613994353504)

GUDID

Device Identifier (DI) Information

Brand Name: ACTIVA® Therapy
Version or Model: 37085-95
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994353504
Issuing Agency: GS1
Commercial Distribution End Date: August 13, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: EXT 37085-95 ACTIVA RC 8-4 US MKT

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:	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
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
MRU	implanted subcortical electrical Stimulator (motor disorders)
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H020007	051
H050003	021
P960009	051

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: 95.0 Centimeter

Device Record Status

Public Device Record Key: 1a01ee1f-be40-478b-9cc9-5f0f3da5b3e8
Public Version Date: October 02, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2014