AccessGUDID - DEVICE: Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist (00792293044211)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist
Version or Model: 4421
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4421
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293044211
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 38" TO 46" (97CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94401 & #4401.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
45376	Penis/scrotum wearable urinal	A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNX	Device, Incontinence, Urosheath Type, Non-Sterile

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Weight: 0.18 Pound
Device Size Text, specify: 38" to 46" Wasit
Device Size Text, specify: 97cm to 117cm Waist

Device Record Status

Public Device Record Key: 1f14ae98-ce57-453f-af25-444e4fb14893
Public Version Date: October 23, 2024
Public Version Number: 3
DI Record Publish Date: April 12, 2018