AccessGUDID - DEVICE: Evoke® Pocket Console (EPC) (09352307000025)

GUDID

Device Identifier (DI) Information

Brand Name: Evoke® Pocket Console (EPC)
Version or Model: 3040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3040
Company Name: SALUDA MEDICAL PTY LIMITED

Primary DI Number: 09352307000025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 744596461 *Terms of Use

Device Description: No description.

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
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190002	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 -20 and 60 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ffa6180-5b27-431e-bf05-17b0809ad1e1
Public Version Date: October 09, 2023
Public Version Number: 2
DI Record Publish Date: March 15, 2022