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Urocare® Straight-Thru Adapter with Thumb Clamp 5.5" (14cm)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Urocare® Straight-Thru Adapter with Thumb Clamp 5.5" (14cm) FDA UDI
- Generic Name
- Penis/scrotum wearable urinal FDA UDI
- Device Name
- TUBE, WHITE-RUBBER, OSTOMY/URINE COLLECTION, THREADED ADAPTER, CLAMP, REUSABLE Includes: 1 Tube with Threaded Adapter, 1 Thumb Clamp (#7000) and 1 Black Gasket-Ring (#5999) preassembled. FDA UDI
- Model / Reference
- 6005 FDA UDI
- Description
- TUBE, WHITE-RUBBER, OSTOMY/URINE COLLECTION, THREADED ADAPTER, CLAMP, REUSABLE Includes: 1 Tube with Threaded Adapter, 1 Thumb Clamp (#7000) and 1 Black Gasket-Ring (#5999) preassembled. FDA UDI
Identifiers
- Catalog Number
- 6005 FDA UDI
- Primary DI / UDI-DI
- 00792293060051 FDA UDI
- FDA Product Code
- NNW FDA UDIKNX FDA UDI
- GMDN Term
- Penis/scrotum wearable urinal 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.31 Inch FDA UDIOuter Diameter — 0.44 Inch FDA UDIWeight — 0.03 Pound FDA UDILength — 5.5 Inch FDA UDI
Category: Open-ended wearable urine collection bag, non-sterilePenis/scrotum wearable urinal
Urocare® Straight-Thru Adapter with Thumb Clamp 5.5" (14cm) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Urocare Products, Inc.
Sources (1)
- FDA UDI b8ff6c1d-29d6-482f-b372-3b883a0f4d8b 36 fields · synced May 30, 2026