Identity
- Trade Name
- Transducer EVN4-9 FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Model / Reference
- USP-GN49E0A/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806167740207 FDA UDI
- 510(k) Number
- K133505 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- GMDN Term
- Rectal/vaginal ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 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
Transducer EVN4-9 by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rectal/vaginal ultrasound imaging transducer.
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Cleared under the same submission
K133505 also covers:
- 3DC2-6 — SAMSUNG MEDISON CO., LTD
- ACCESSORY SET — SAMSUNG MEDISON CO., LTD
- ECG Module(AHA) — SAMSUNG MEDISON CO., LTD
- ECG Module(IEC) — SAMSUNG MEDISON CO., LTD
- EV4-9/10ED — SAMSUNG MEDISON CO., LTD
- EV4-9/10ED — SAMSUNG MEDISON CO., LTD
- P2-4 — SAMSUNG MEDISON CO., LTD
- SONOACE R7 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- Transducer 3D4-8 — SAMSUNG MEDISON CO., LTD
- Transducer 3DC2-6 — SAMSUNG MEDISON CO., LTD
- Transducer C2-5 — SAMSUNG MEDISON CO., LTD
- Transducer C2-8 — SAMSUNG MEDISON CO., 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
- Samsung Medison Co., Ltd
Sources (1)
- FDA UDI b8f33902-9e15-4b97-9f90-3d46d31524c5 33 fields · synced Jun 1, 2026