Identity
- Trade Name
- MC9-4 Transducer FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Model / Reference
- 10349999 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869004549 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rectal/vaginal ultrasound imaging transducer
MC9-4 Transducer by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal/vaginal ultrasound imaging transducer.
- V10-4B Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- X14L4 Transducer — Bk Medical ApS · Class II
- Volume probe — CHISON Medical Technologies Co., Ltd. · Class II
- EUP-VV531 — FUJIFILM Corporation · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- EV3-10X — Alpinion Medical Systems Co., Ltd. · Class II
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES · Class II
- Voluson — GE Healthcare Austria GmbH & Co OG · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI a18241dd-6d42-4481-8e46-3bb0546d3d61 34 fields · synced Jun 8, 2026