Identity
- Trade Name
- Probe sensor assembly for GE BE9CS FDA UDI
- Generic Name
- Rectal ultrasound navigational image processor FDA UDI
- Model / Reference
- FPRSA00019 FDA UDI
Identifiers
- Catalog Number
- FPRSA00019 FDA UDI
- Primary DI / UDI-DI
- 07290016936162 FDA UDI
- 510(k) Number
- K100784 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Rectal ultrasound navigational image processor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rectal ultrasound navigational image processor
Probe sensor assembly for GE BE9CS by Uc-Care Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100784 also covers:
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- Endocar Tamplate Fixator — UC-CARE LTD
- Navigo™ Workstation — UC-CARE LTD
- Probe sensor — UC-CARE LTD
- Probe sensor assembly for BK 8667 (square) — UC-CARE LTD
- Probe sensor assembly for BK 8808 (square) — UC-CARE LTD
- Probe sensor assembly for BK 8818 and 8808e (square) — UC-CARE LTD
- Probe sensor assembly for Civco 8848 — UC-CARE LTD
- Probe sensor assembly for D&K 8848 — UC-CARE LTD
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
- Uc-Care Ltd
Sources (1)
- FDA UDI 56a86266-2bb5-4c19-916a-4afcd0e9e50e 34 fields · synced Jun 1, 2026