Identity
- Trade Name
- EV29L Transrectal Transducer FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- EV29L is a 29 MHz high resolution transrectal side-fire transducer. FDA UDI
- Model / Reference
- EV29L FDA UDI
- Description
- EV29L is a 29 MHz high resolution transrectal side-fire transducer. FDA UDI
Identifiers
- Catalog Number
- EV-29L FDA UDI
- Primary DI / UDI-DI
- 00628055481034 FDA UDI
- 510(k) Number
- K162972 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
No
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
Category: Rectal/vaginal ultrasound imaging transducer
EV29L Transrectal Transducer by Exact Imaging — 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
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- 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
Cleared under the same submission
K162972 also covers:
- EV29L Non-Sterile Reusable PrecisionPoint Adapter — Exact Imaging
- EV9C Transrectal Transducer — Exact Imaging
- ExactVu High Resolution Micro-Ultrasound System — Exact Imaging
- ExactVu High Resolution Micro-Ultrasound System — Exact Imaging
- Needle Guide for use with the Exact Imaging EV29L Transducer — Exact Imaging
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
- Exact Imaging
Sources (1)
- FDA UDI e1328596-4a3e-4ee1-8f39-190145e3b7e3 35 fields · synced May 30, 2026