Identity
- Trade Name
- Clear Advantage Spirit Adhesive Sheath FDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- Clear Advantage Spirit Hydrocolloid Adhesive Sheath FDA UDI
- Model / Reference
- 5403 FDA UDI
- Description
- Clear Advantage Spirit Hydrocolloid Adhesive Sheath FDA UDI
Identifiers
- Catalog Number
- 5403 FDA UDI
- Primary DI / UDI-DI
- 00801741071607 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 40 Millimeter FDA UDI
Category: Urinary incontinence penis sheath/port, single-use
Clear Advantage Spirit Adhesive Sheath by C. R. Bard, 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
- LHB Industries — The Lighthouse For the Blind, Inc. · Class I
- LHB Industries — The Lighthouse For the Blind, Inc. · Class I
- Uro-Con® Teaxs-Style Male External Catheter, Small 25mm 4" Tube — UROCARE PRODUCTS, INC. · Class I
- InView Special — Hollister Incorporated · Class I
- Freedom Clear — Coloplast A/S · Class I
- Freedom Cath — Coloplast A/S · Class I
- Uro-Bond® III Brush-On Silicone Adhesive 3 oz. (88.7 mL.) — UROCARE PRODUCTS, 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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 810a9560-1ec3-44b6-aaf9-ee27a59ef767 36 fields · synced May 31, 2026