AccessGUDID - DEVICE: Pathway® (00852423006189)

GUDID

Device Identifier (DI) Information

Brand Name: Pathway®
Version or Model: 6340
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6340
Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Primary DI Number: 00852423006189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625863568 *Terms of Use

Device Description: Pathway® 6340 Rectal EMG/Stimulation Sensor

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:	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?
66774	Perineal orifice incontinence-control electrical stimulation system probe, single-use	An invasive electrical conductor which is a component of a perineal orifice incontinence-control electrical stimulator intended for the treatment of urinary and/or faecal incontinence, by a healthcare professional, through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (via a cable or wirelessly) and is in the form of a cylinder-like probe with surface electrodes for insertion into the vagina and/or anus whereby therapy involves induction of Kegel-like contractions. This is a single-use device.	Active	false
32686	Perineometer	A device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b523e5d1-fd2f-4717-963a-195478c7458b
Public Version Date: July 18, 2024
Public Version Number: 5
DI Record Publish Date: September 26, 2016