Identity
- Trade Name
- HS AMICA FDA UDI
- Generic Name
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
- Device Name
- RF AMICA-PROBE 17GX200MM EXP. TIP 20MM FDA UDI
- Model / Reference
- RF AMICA-PROBE FDA UDI
- Description
- RF AMICA-PROBE 17GX200MM EXP. TIP 20MM FDA UDI
Identifiers
- Catalog Number
- RF17200E20V1 FDA UDI
- Primary DI / UDI-DI
- 08058983740941 FDA UDI
- 510(k) Number
- K150112 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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 Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 17 Gauge FDA UDILength — 200 Millimeter FDA UDI
Category: Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
Hs Amica by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal.
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Cleared under the same submission
K150112 also covers:
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
- HS AMICA — H.S. HOSPITAL SERVICE SPA
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
- H.s. Hospital Service Spa
Sources (1)
- FDA UDI 08b8160f-b708-425f-a75d-f332ed3d8445 37 fields · synced Jun 8, 2026