AccessGUDID - DEVICE: St. Jude Medical Infinity™ (05415067020697)

GUDID

Device Identifier (DI) Information

Brand Name: St. Jude Medical Infinity™
Version or Model: DBS System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6173
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067020697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: 8CH Directional Lead, 40 cm, 1.5

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140009	001

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
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Special Storage Condition, Specify: Store components and their packaging where they will not come in contact with liquids of any kind.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d4e7de4-3773-441c-b22e-7ad62572f2f9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016