Identity
- Trade Name
- Seed Slider EUDAMEDStandard Imaging Seed Slider FDA UDI
- Generic Name
- Radiation shielding container, general-purpose FDA UDI
- Device Name
- Brachytherapy Tools EUDAMEDStandard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles. FDA UDI
- Model / Reference
- 90090 EUDAMEDFDA UDI
- Description
- Standard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles. FDA UDI
Identifiers
- Catalog Number
- 90090 FDA UDI
- Primary DI / UDI-DI
- 00850019946031 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946SEEDHANDLINGVX EUDAMED
- Direct Marketing DI
- 00850019946031 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 Seed Slider 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 76aabd25-916c-439e-b3c1-52e57528dcad 34 fields · synced Jul 22, 2026
- EUDAMED 54d693db-4039-4a96-8d29-f5252f85fb99 61 fields · synced Jul 22, 2026