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HS iBEAM evo Extension Basic Module PushPIN long
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref P10107-414Ref P10107-416
Identity
- Trade Name
- HS iBEAM evo Extension Basic Module PushPIN long EUDAMEDFDA UDIHS iBEAM evo Extension Basic Module PushPIN EUDAMEDHS iBEAM evo Extension Push Pin FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Extensions EUDAMED
- Model / Reference
- P10107-416 EUDAMEDFDA UDIP10107-414 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120074394162 EUDAMEDFDA UDI09120074394148 EUDAMEDFDA UDI
- Basic UDI-DI
- 91200743939ME EUDAMED
- Direct Marketing DI
- 09120074394148 EUDAMED09120074394162 EUDAMED
- 510(k) Number
- K081218 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological whole-body positioner
HS iBEAM evo Extension Basic Module PushPIN long by IT-V Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Radiological whole-body positioner.
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Cleared under the same submission
K081218 also covers:
- BellySTEP Baseplate — IT-V Medizintechnik GmbH
- BellySTEP Baseplate cut out long — IT-V Medizintechnik GmbH
- BellySTEP Baseplate no cut out — IT-V Medizintechnik GmbH
- BellySTEP Insert A - Medium — IT-V Medizintechnik GmbH
- BreastSTEP Mask 2mm (5 pcs.) — IT-V Medizintechnik GmbH
- Distance Plate PushPIN — IT-V Medizintechnik GmbH
- FoamSTEP Comfort Module Grey 180 x 45 x 3cm — IT-V Medizintechnik GmbH
- FoamSTEP Roll 300 x 70 Dm — IT-V Medizintechnik GmbH
- FoamSTEP Semiroll 400 x 220 x 220 Dm (H110) — IT-V Medizintechnik GmbH
- FoamSTEP Wedge 130 x 250 x 60 to 0 — IT-V Medizintechnik GmbH
- GreyBAG Adapter — IT-V Medizintechnik GmbH
- HS Independent Indexing Clamp 500, Offcentered — IT-V Medizintechnik GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- IT-V Medizintechnik GmbH
Sources (4)
- FDA UDI 9232ba91-c148-4d25-b92c-2aec4725bd7d 33 fields · synced Jul 11, 2026
- FDA UDI 30ec7170-dc4d-4e5d-85bf-23adb7f6d673 33 fields · synced May 30, 2026
- EUDAMED 9fe7fc79-c84e-4466-93a0-206b1dcc4031 61 fields · synced Jul 10, 2026
- EUDAMED 0ef95bb6-b9b3-4566-9388-495681b95cdf 61 fields · synced Jul 11, 2026