Standard Imaging Needle Loading Shield
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Needle Loading Shield EUDAMEDStandard Imaging Needle Loading Shield FDA UDI
- Generic Name
- Radiation shielding container, general-purpose FDA UDI
- Device Name
- Brachytherapy Tools EUDAMEDStandard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into needles in a radiation shielded environment. FDA UDI
- Model / Reference
- 90070 EUDAMEDFDA UDI
- Description
- Standard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into needles in a radiation shielded environment. FDA UDI
Identifiers
- Catalog Number
- 90070 FDA UDI
- Primary DI / UDI-DI
- 00850019946048 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946SEEDHANDLINGVX EUDAMED
- Direct Marketing DI
- 00850019946048 EUDAMED
- FDA Product Code
- KPY FDA UDI
- EMDN Code
- Z11010280 INSTRUMENTS FOR RADIOTHERAPY SIMULATION - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation shielding container, general-purpose FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Radiation shielding container, general-purpose
Standard Imaging Needle Loading Shield by Standard Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (2)
- FDA UDI 0c5dbb1c-9b21-48e9-9821-e50ecb7138df 34 fields · synced Jul 16, 2026
- EUDAMED 0f07d584-07f3-41a5-b0c0-17a74000112e 61 fields · synced Jul 16, 2026