AccessGUDID - DEVICE: FemSoft® Insert Female Urethral Insert (00801741011061)

GUDID

Device Identifier (DI) Information

Brand Name: FemSoft® Insert Female Urethral Insert
Version or Model: 71201
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71201
Company Name: Rochester Medical Corporation

Primary DI Number: 00801741011061
Issuing Agency: GS1
Commercial Distribution End Date: May 12, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 605440718 *Terms of Use

Device Description: Female Urethral Insert

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:	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?
45333	Female-incontinence urethral balloon	A sterile, female urinary incontinence device (a balloon-like plug) designed to be placed into the urethral opening and inflated to occlude the urethra and prevent involuntary urination/dribbling for females who are incontinent of the bladder. It is typically made of plastic and textile materials and is designed to be inflated using an external inflation device. It is removed by the user when voiding and discarded. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCK	Transurethral occlusion insert, urinary incontinence-control, female

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: Yes
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
Length: 3.5 Centimeter

Device Record Status

Public Device Record Key: ad0dd887-6fac-44de-8a5f-fad727bfccd3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 30, 2015