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
- P06841-05 FDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- P06841 FDA UDI
- Primary DI / UDI-DI
- 00841517103699 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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal ultrasound imaging transducer, reusable.
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- Sonoscape — SONOSCAPE MEDICAL CORP. · Class II
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 (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
- Fujifilm Sonosite, Inc.
Sources (1)
- FDA UDI 2f79e520-8d32-49b1-bdfa-b304a66294ba 37 fields · synced Jun 7, 2026