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David
FDA UDIClass II (US FDA UDI)
by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Identity
- Trade Name
- DAVID FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, anthropomorphic FDA UDI
- Model / Reference
- DAVID Elekta MLC-80 FDA UDI
Identifiers
- Catalog Number
- T34065 FDA UDI
- Primary DI / UDI-DI
- EPTWT340650 FDA UDI
- 510(k) Number
- K062817 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Multi-modality therapeutic radiation phantom, anthropomorphic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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: Multi-modality therapeutic radiation phantom, anthropomorphic
David by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062817 also covers:
- DAVID — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- DAVID — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- DAVID — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- DAVID — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- DAVID — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
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
Sources (1)
- FDA UDI fabe9d13-c433-475c-a79f-dc7897f805e9 34 fields · synced Jun 9, 2026