Identity
- Trade Name
- C12-4lp Laparoscope Transducer 89200-00 FDA UDI
- Generic Name
- Surgical ultrasound imaging transducer FDA UDI
- Model / Reference
- C12-4lp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415919382 FDA UDI
- 510(k) Number
- K192410 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Surgical 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: Surgical ultrasound imaging transducer
C12-4lp Laparoscope Transducer 89200-00 by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Surgical ultrasound imaging transducer.
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- UST-5543 — FUJIFILM Corporation · Class II
Cleared under the same submission
K192410 also covers:
- L30-8 Linear Array Tranducer 87150-00 — Shenzhen Mindray Bio-Medical Electronics Co.
- P7-3c Phased Array Tranducer 89100-00 — Shenzhen Mindray Bio-Medical Electronics Co.
- USB Foot Pedal — Shenzhen Mindray Bio-Medical Electronics Co.
- ViewMate — Shenzhen Mindray Bio-Medical Electronics Co.
- ZS3 Elite Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- ZS3KP Elite Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- ZS4 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- z.one pro Diagnostic Ultrasound System — 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 a4cda3d0-f83c-418b-9c8d-a0e43080f9a8 33 fields · synced May 30, 2026