Identity
- Trade Name
- Clarity® FDA UDI
- Generic Name
- Ultrasound patient positioning system FDA UDI
- Device Name
- Clarity® TPUS Autoscan Probe Base Kit FDA UDI
- Model / Reference
- 9100-00061 FDA UDI
- Description
- Clarity® TPUS Autoscan Probe Base Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540180000115 FDA UDI
- FDA Product Code
- IWB FDA UDIKPQ FDA UDIIYE FDA UDI
- GMDN Term
- Ultrasound patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5750 FDA UDI892.5840 FDA UDI892.5050 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
Clarity® by Elekta Solutions AB — 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
- Elekta Solutions AB
Sources (1)
- FDA UDI ee8372d9-c1a1-4d5b-9f85-816e5eb5247c 36 fields · synced Jun 1, 2026