Identity
- Trade Name
- 16 MHz probe, 1mm with adapter cable FDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- 16 MHz probe Ø 1.0 mm (soft cable) with adapter cable for patient isolation FDA UDI
- Model / Reference
- 16 MHz_1S FDA UDI
- Description
- 16 MHz probe Ø 1.0 mm (soft cable) with adapter cable for patient isolation FDA UDI
Identifiers
- Catalog Number
- 6586 FDA UDI
- Primary DI / UDI-DI
- 04260493310819 FDA UDI
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive vascular ultrasound system probe
16 MHz probe, 1mm with adapter cable by Compumedics Germany GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051085 also covers:
- 1 MHz Monitoring Adapter — Compumedics Germany GmbH
- 1 MHz probe, handheld — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 16 MHz probe, 1mm — Compumedics Germany GmbH
- 16 MHz probe, 2mm — Compumedics Germany GmbH
- 2 MHz probe, handheld — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring, MRI — Compumedics Germany GmbH
- 2 MHz probe, monitoring, MRI — Compumedics Germany GmbH
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
- Compumedics Germany GmbH
Sources (1)
- FDA UDI bee6b7d6-2f96-449d-8a6d-1d54badf0718 36 fields · synced Jun 6, 2026