Standard Imaging Reconstruction Jig Small
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Reconstruction Jig (Small) EUDAMEDStandard Imaging Reconstruction Jig Small FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, test object FDA UDI
- Device Name
- Reconstruction Jig EUDAMEDStandard Imaging Reconstruction Jig Small allows spatial localization of catheters or other setups for HDR brachytherapy applications. It allows determination of the position of objects in space to a high degree of accuracy. FDA UDI
- Model / Reference
- 91285 EUDAMEDFDA UDI
- Description
- Standard Imaging Reconstruction Jig Small allows spatial localization of catheters or other setups for HDR brachytherapy applications. It allows determination of the position of objects in space to a high degree of accuracy. FDA UDI
Identifiers
- Catalog Number
- 91285 FDA UDI
- Primary DI / UDI-DI
- 00850019946574 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019946RECONJIGXH EUDAMED
- FDA Product Code
- IXG FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-modality therapeutic radiation phantom, test object FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1950 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
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multi-modality therapeutic radiation phantom, test object
Standard Imaging Reconstruction Jig Small 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 e0b7abcf-6e54-40be-bb12-e20e3ed0fbe6 34 fields · synced Jul 19, 2026
- EUDAMED 45733224-7720-42c5-aa65-8619b9f3c289 61 fields · synced Jul 19, 2026