Identity
- Trade Name
- Alatus FDA UDI
- Generic Name
- Radiation therapy lesion localization urethral catheter, planning FDA UDI
- Device Name
- Alatus Vaginal Balloon Packing System FDA UDI
- Model / Reference
- VBP-40 FDA UDI
- Description
- Alatus Vaginal Balloon Packing System FDA UDI
Identifiers
- Primary DI / UDI-DI
- H787VBP400 FDA UDI
- 510(k) Number
- K092534 FDA UDI
- FDA Product Code
- JAQ FDA UDIIYE FDA UDI
- GMDN Term
- Radiation therapy lesion localization urethral catheter, planning FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI892.5050 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Radiation therapy lesion localization urethral catheter, planning
Alatus by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy lesion localization urethral catheter, planning.
- Raypilot Viewcath — Micropos Medical AB (Publ) · Class II
Cleared under the same submission
K092534 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc
Sources (1)
- FDA UDI 9f337522-a769-481e-b5a9-fea3db11a0f0 35 fields · synced Jun 20, 2026