Identity
- Trade Name
- Ultrasonix Medical Corporation FDA UDI
- Generic Name
- Rectal/vaginal ultrasound imaging transducer FDA UDI
- Device Name
- 4DEC9-5/10, 4D motor-driven electronic Endocavity Microconvex Transducer FDA UDI
- Model / Reference
- 00.035.060 FDA UDI
- Description
- 4DEC9-5/10, 4D motor-driven electronic Endocavity Microconvex Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08294360350604 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
- Not 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
Ultrasonix Medical Corporation by Analogic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Analogic Corporation
Sources (1)
- FDA UDI 59bf65f7-9bf2-4015-aaf7-c88b470c7c1d 35 fields · synced May 31, 2026