Uro-Strap® Universal Fabric Male External Catheter Strap 4.75" Economy Pack

Basic Information

• Brand Name: Uro-Strap® Universal Fabric Male External Catheter Strap 4.75" Economy Pack
• Primary DI: 00792293064011
• Version / Model: 6401
• Catalog Number: 6401
• Company Name: UROCARE PRODUCTS, INC.
• Labeler DUNS: 070637129
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-30
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: a21c9739-0dc1-4a5d-af1b-8ac59f770d3b

Device Description

STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLE, ECONOMY The Uro-Strap® is an economical solution to numerous changes of tapes and adhesive strips. An elasticized cotton & loop construction allows the self-gripping fastener to attach itself anywhere along the length of the strap making it fully adjustable to individual requirements which provides security and aids in a comfortable fit. Contains: 10 Fabric Catheter Straps, Use and Care Instructions

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34929	Urinary incontinence penis sheath/port, single-use	A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00792293064011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	0.01	Pound
Device Size Text, specify			1" wide by 4.75" Long (2.54cm x 12cm)