AccessGUDID - DEVICE: ReActiv8 Programming Wand (05391527770213)

GUDID

Device Identifier (DI) Information

Brand Name: ReActiv8 Programming Wand
Version or Model: 6M6000-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6000
Company Name: MAINSTAY MEDICAL LIMITED

Primary DI Number: 05391527770213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985519015 *Terms of Use

Device Description: Programming Wand

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?
62425	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer	A portable, electrically-powered component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to be used by a healthcare professional to program the pulse generator component with patient-specific parameters; a tester and/or dedicated software may be included. The system is designed to deliver episodic electrical stimulation to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for the relief/treatment of acute and/or chronic intractable pain [e.g., chronic low back pain (CLBP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLK	Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190021	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9bacf3a2-f7fe-49c2-ab49-50d3f8509934
Public Version Date: June 08, 2021
Public Version Number: 3
DI Record Publish Date: January 25, 2021