Identity
- Trade Name
- Spirit® Hydrocolloid Adhesive Sheath FDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- Spirit® Hydrocolloid Adhesive Sheath FDA UDI
- Model / Reference
- 37105 FDA UDI
- Description
- Spirit® Hydrocolloid Adhesive Sheath FDA UDI
Identifiers
- Catalog Number
- 37105 FDA UDI
- Primary DI / UDI-DI
- 00801741071164 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
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
Dimensions & Sizes
- Size
- Circumference — 41 Millimeter FDA UDI
Category: Urinary incontinence penis sheath/port, single-use
For patients with urinary incontinence, the Spirit Hydrocolloid Adhesive Sheath offers a convenient and effective solution for managing urinary leaks. This single-use device is designed to channel urine from the penis into a collection bag, providing an alternative to traditional catheter insertion methods.
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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
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 6b856916-38c9-49db-b0f6-1e6ef272add0 36 fields · synced Jun 23, 2026