AccessGUDID - DEVICE: Freedom Spinal Cord Stimulator System (00859619004028)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom Spinal Cord Stimulator System
Version or Model: WAA-A011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WAA-A011
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00859619004028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078294927 *Terms of Use

Device Description: Boogieboard Wearable Antenna Assembly 915

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:	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?
61588	Implantable spinal cord electrical stimulation system programmer	A battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.	Active	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 [?]
K141399	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
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a9f2000-bb85-4aa0-b103-5cffbbec052d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 13, 2016