BottomStop Adaption
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- BottomStop Adaption FDA UDIOmniBoard™ bottomstop FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Bottomstop EUDAMEDBottomstop adaption to fit on BreastBoard to assist the shorter patient FDA UDIOmniBoard bottomstop FDA UDI
- Model / Reference
- 122590 EUDAMED126160 EUDAMED174270 EUDAMEDBSS FDA UDIUATB-BS FDA UDI
- Description
- Bottomstop adaption to fit on BreastBoard to assist the shorter patient FDA UDIOmniBoard bottomstop FDA UDI
Identifiers
- Catalog Number
- 122590 FDA UDI126160 FDA UDI
- Primary DI / UDI-DI
- 08719425702155 EUDAMEDFDA UDI08719425704371 EUDAMEDFDA UDI08720168163240 EUDAMED
- Basic UDI-DI
- 872016816126160JJ EUDAMED
- 510(k) Number
- K142420 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMEDNorthern Ireland 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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Indexed-immobilization patient positioning system
BottomStop Adaption by Macromedics B.v. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (6)
- FDA UDI db577ade-ce8d-4cf9-bfce-ffd2b778e77e 34 fields · synced Jul 27, 2026
- FDA UDI fc3557fb-7953-4626-bb9d-24035dfc26a0 35 fields · synced May 29, 2026
- EUDAMED 015c30c2-b841-4264-8c59-341f532bad2d 61 fields · synced Jul 8, 2026
- EUDAMED 5c7ffd46-9418-435c-a9ed-46ab32a534a6 61 fields · synced Jul 9, 2026
- EUDAMED c7a314b5-f078-4bc0-aa6a-86d3faf38637 61 fields · synced Jul 20, 2026
- EUDAMED 411af9fc-2643-4b72-8af1-4154094ee17b 61 fields · synced Jul 27, 2026