AccessGUDID - DEVICE: Freedom Spinal Cord Stimulator System (00859619004097)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom Spinal Cord Stimulator System
Version or Model: FR4A-TRL-A0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S4T-1A US
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00859619004097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078294927 *Terms of Use

Device Description: Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US

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:	Yes
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?
36007	Analgesic spinal cord electrical stimulation system	An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150517	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.35 Millimeter
Weight: 0.25 Gram
Length: 45 Centimeter

Device Record Status

Public Device Record Key: 952c4aba-209d-4d28-84f9-572eb45c32da
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 11, 2016