Identity
- Trade Name
- TEEx/8-3 MHz FDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Device Name
- Diagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- P05183-18 FDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517100636 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable 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
Category: Oesophageal ultrasound imaging transducer, reusable
TEEx/8-3 MHz by Fujifilm Sonosite, Inc. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal ultrasound imaging transducer, reusable.
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Cleared under the same submission
K053069 also covers:
K130173 also covers:
K133454 also covers:
- Battery — Fujifilm Sonosite, Inc.
- Edge Mini-Dock — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA UDI d6faf0ff-dfa9-4f0a-ae2d-08d0e9d1958a 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026