Identity
- Trade Name
- Terason FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- The Terason 8EC4A is an endocavity ultrasound transducer array. The intended uses include: fetal, trans-rectal, and trans-vaginal ultrasound imaging. FDA UDI
- Model / Reference
- 8EC4A FDA UDI
- Description
- The Terason 8EC4A is an endocavity ultrasound transducer array. The intended uses include: fetal, trans-rectal, and trans-vaginal ultrasound imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852698007034 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
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 transducerHand-held ultrasound imaging system, body-surfaceRectal ultrasound imaging system transducer
Terason by Teratech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Teratech Corporation
Sources (1)
- FDA UDI 8c040e3c-c498-4038-9123-4c481618fa1f 34 fields · synced May 30, 2026