Identity
- Trade Name
- Needle Cradle EUDAMEDStandard Imaging Needle Cradle FDA UDI
- Generic Name
- Radiation shielding container, general-purpose FDA UDI
- Device Name
- Brachytherapy Tools EUDAMEDStandard Imaging Needle Cradle is designed for storage of loaded LDR prostate implant needles, prior to use in a patient. FDA UDI
- Model / Reference
- 90095 EUDAMEDFDA UDI
- Description
- Standard Imaging Needle Cradle is designed for storage of loaded LDR prostate implant needles, prior to use in a patient. FDA UDI
Identifiers
- Catalog Number
- 90095 FDA UDI
- Primary DI / UDI-DI
- 00850019946062 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946SEEDHANDLINGVX EUDAMED
- Direct Marketing DI
- 00850019946062 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 Cradle 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 9e940227-4c9d-4f5d-b9bd-292e5855cc62 34 fields · synced Jul 9, 2026
- EUDAMED 66514f95-eadb-4a5e-ad53-9a973cdd99f0 61 fields · synced Jul 9, 2026