AccessGUDID - DEVICE: Bioness StimRouter Extended Hydrogel Electrode Set (00815962020313)

GUDID

Device Identifier (DI) Information

Brand Name: Bioness StimRouter Extended Hydrogel Electrode Set
Version or Model: ST2-7001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIONESS INC.

Primary DI Number: 00815962020313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: Extended Hydrogel Electrode Set

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	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?
65318	Transcutaneous electrical stimulation electrode, reusable	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Degrees Celsius
Special Storage Condition, Specify: KiloPascal
Special Storage Condition, Specify: Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 27 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 25 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d4a1c1a-2689-491a-8361-2f898cd7cb70
Public Version Date: September 20, 2021
Public Version Number: 5
DI Record Publish Date: March 31, 2019