Identity
- Trade Name
- OmniBoard™ BTM-SX-EX EUDAMEDOmniBoard™ BTM FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- BreastBoard EUDAMEDOmniBoard Breast Treatment Module FDA UDI
- Model / Reference
- 126140 EUDAMEDUATB-BTM FDA UDI
- Description
- OmniBoard Breast Treatment Module FDA UDI
Identifiers
- Catalog Number
- 126140 FDA UDI
- Primary DI / UDI-DI
- 08719425704357 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816122500HQ 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
- Northern 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
No
Category: Indexed-immobilization patient positioning system
OmniBoard™ BTM by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K142420 also covers:
- Adaptor MaxSupport™ TO — MACROMEDICS B.V.
- Adaptor MaxSupport™ TS — MACROMEDICS B.V.
- Block high CF ExaFix™ — MACROMEDICS B.V.
- Block low CF ExaFix™ — MACROMEDICS B.V.
- BreastBoardLX™ — MACROMEDICS B.V.
- CouchStrip CSMF — MACROMEDICS B.V.
- CouchStrip CSMFGF — MACROMEDICS B.V.
- CouchStrip CSNF — MACROMEDICS B.V.
- CouchStrip CSNFCF — MACROMEDICS B.V.
- CouchStrip CSWF — MACROMEDICS B.V.
- DSCP™ KS indexstrip — MACROMEDICS B.V.
- DSPS® Cradle-MEXF H MR — MACROMEDICS B.V.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI fc43f380-6d7c-470d-8fc7-18a797fbe8e2 35 fields · synced Jul 10, 2026
- EUDAMED 5e9d602d-97c4-4500-b924-cccd5eb028b4 61 fields · synced Jul 10, 2026