Identity
- Trade Name
- E9-4 Ultrasonic Probe(FDA) 84002-40 FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Model / Reference
- Z103-40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415902780 FDA UDI
- 510(k) Number
- K171891 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
Yes
FDA UDI
Liquid Chemical FDA UDI
MR Unsafe FDA UDI
Category: Rectal/vaginal ultrasound imaging transducer
E9-4 Ultrasonic Probe(FDA) 84002-40 by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171891 also covers:
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- E9-3 Endocavitary Tranducer 87444-30 — Shenzhen Mindray Bio-Medical Electronics Co.
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- P8-3TEE Echocardiography Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
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- P8-3mTEE Ped Echocardiography Transducer — Shenzhen Mindray Bio-Medical Electronics Co.
- SONY UP-D711MD Black &White Printer(KP+) — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 97c4ebea-3f23-430f-825a-f488697c0c7b 34 fields · synced May 30, 2026