Identity
- Trade Name
- URO TRAY FDA UDI
- Generic Name
- Urological fluid funnel FDA UDI
- Device Name
- URO TRAY ONLY 5001/6001/1201/ 1200/6000/6500 FDA UDI
- Model / Reference
- 4-040-03-2 FDA UDI
- Description
- URO TRAY ONLY 5001/6001/1201/ 1200/6000/6500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736112776 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Urological fluid funnel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urological fluid funnel
Uro Tray by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urological fluid funnel.
- JAC-CELL Medic — TIDI PRODUCTS, LLC · Class II
- Vital Care — TIDI PRODUCTS, LLC · Class II
- Steris — TIDI PRODUCTS, LLC · Class II
- Sterimed — Sterimed, Inc. · Class I
- JAC-CELL Medic — TIDI PRODUCTS, LLC · Class II
- Skytron — TIDI PRODUCTS, LLC · Class II
- Siemens Medical Solutions — TIDI PRODUCTS, LLC · Class II
- Biodex Medical Systems — TIDI PRODUCTS, LLC · Class II
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
- Skytron, LLC
Sources (1)
- FDA UDI c047dcca-c079-4c0c-ad79-597d0fe94cef 34 fields · synced May 30, 2026