Identity
- Trade Name
- Phantom FDA UDI
- Generic Name
- Bone densitometry ultrasound phantom, test object FDA UDI
- Model / Reference
- 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B214OSPTM3 FDA UDI
- FDA Product Code
- KGI FDA UDI
- GMDN Term
- Bone densitometry ultrasound phantom, test object FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1170 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CT phantom, test objectMulti-modality diagnostic imaging phantom, test objectGeneral-purpose diagnostic x-ray phantom, test objectDiagnostic ultrasound phantom, test object
Phantom by medimaps group SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone densitometry ultrasound phantom, test object.
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
- medimaps group SA
Sources (1)
- FDA UDI 6da5bd10-c978-43db-91af-e1c7d53b0bf8 32 fields · synced May 30, 2026