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Uro-Strap® Fabric Universal Male External Catheter Strap 4.75"
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Uro-Strap® Fabric Universal Male External Catheter Strap 4.75" FDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLE 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: 1 Fabric Catheter Strap, Use and Care Instructions FDA UDI
- Model / Reference
- 6400 FDA UDI
- Description
- STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLE 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: 1 Fabric Catheter Strap, Use and Care Instructions FDA UDI
Identifiers
- Catalog Number
- 6400 FDA UDI
- Primary DI / UDI-DI
- 00792293064004 FDA UDI
- FDA Product Code
- NNX FDA UDI
- GMDN Term
- Urinary incontinence penis sheath/port, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.01 Pound FDA UDI
Category: Urinary incontinence penis sheath/port, single-use
Uro-Strap® Fabric Universal Male External Catheter Strap 4.75" by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Urinary incontinence penis sheath/port, single-use.
- Wideband™ Self-Adhering Male External Catheter — C. R. Bard, Inc. · Class I
- UltraFlex™ Self-Adhering Male External Catheter — C. R. Bard, Inc. · Class I
- LHB Industries — The Lighthouse For the Blind, Inc. · Class I
- SureStep Male External Catheter System Green Replacement Kit — C. R. Bard, Inc. · Class I
- Clear Advantage Male Continence Sheath — C. R. Bard, Inc. · Class I
- Wideband Male External Catheter — C. R. Bard, Inc. · Class I
- LHB Industries — The Lighthouse For the Blind, Inc. · Class I
- Spirit® Hydrocolloid Adhesive Sheath — C. R. Bard, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Urocare Products, Inc.
Sources (1)
- FDA UDI 0f9727d4-6674-46dc-9a72-f066c55100c1 36 fields · synced May 30, 2026