AccessGUDID - DEVICE: ReActiv8 Magnet (05391527770626)

GUDID

Device Identifier (DI) Information

Brand Name: ReActiv8 Magnet
Version or Model: 6M4000-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4000
Company Name: MAINSTAY MEDICAL LIMITED

Primary DI Number: 05391527770626
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 985519015 *Terms of Use

Device Description: ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).

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?
57996	Active implantable device control magnet	A hand-operated, non-sterile, magnetic device designed to be used by a patient and a healthcare professional to switch an active implantable device (e.g., pulse generator, implantable cardiac monitor) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implant and turned as prescribed by the manufacturer. This is a reusable device.	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: e80e17ab-a1da-40b1-93c1-0716c0e1c9b0
Public Version Date: May 23, 2025
Public Version Number: 3
DI Record Publish Date: January 25, 2021