Identity
- Trade Name
- LHB Industries FDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- Male Ext Catheter, Large 36mm, Non Latex w/Skin wipe FDA UDI
- Model / Reference
- Ultra Flex Large w/wipe FDA UDI
- Description
- Male Ext Catheter, Large 36mm, Non Latex w/Skin wipe FDA UDI
Identifiers
- Catalog Number
- 2204043 FDA UDI
- Primary DI / UDI-DI
- 00009235421857 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Urinary incontinence penis sheath/port, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urinary incontinence penis sheath/port, single-use
LHB Industries by The Lighthouse For the Blind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary incontinence penis sheath/port, single-use.
- Urofoam®-1 Single-Sided Adhesive Foam Strip Box of 50 — UROCARE PRODUCTS, INC. · Class I
- Wideband™ Self-Adhering Male External Catheter — C. R. Bard, Inc. · Class I
- UltraFlex™ Self-Adhering Male External Catheter — C. R. Bard, 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
- Spirit® Hydrocolloid Adhesive Sheath — C. R. Bard, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Lighthouse For the Blind, Inc.
Sources (1)
- FDA UDI ef729795-0f91-49f1-8574-b9ccbfe350e0 35 fields · synced May 30, 2026