AccessGUDID - DEVICE: Probe, Manometry, Vaginal Sensor (00627825011013)

GUDID

Device Identifier (DI) Information

Brand Name: Probe, Manometry, Vaginal Sensor
Version or Model: PRB113
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Laborie Medical Technologies Canada ULC

Primary DI Number: 00627825011013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203383526 *Terms of Use

Device Description: No description.

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):	No
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?
36050	Perineal orifice incontinence-control electrical stimulation system probe, reusable	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 through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (not included) 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. It is intended for use in both the home (self-treatment) and healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIR	PERINEOMETER

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: 1525b663-350a-46a3-b681-f60c62785a38
Public Version Date: June 02, 2023
Public Version Number: 4
DI Record Publish Date: September 01, 2017