System BreastSTEP indexed long Mask
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- System BreastSTEP indexed long Mask EUDAMEDFDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- BreastSTEP Systems EUDAMED
- Model / Reference
- P10107-727 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120074397279 EUDAMEDFDA UDI
- Basic UDI-DI
- 91200743912LS EUDAMED
- Direct Marketing DI
- 09120074397279 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
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
No
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: Radiological whole-body positioner
System BreastSTEP indexed long Mask by IT-V Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
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
- IT-V Medizintechnik GmbH
Sources (2)
- FDA UDI e0437739-a6a7-475c-a0b8-590dee91d76d 33 fields · synced Jul 29, 2026
- EUDAMED 85e227cb-556d-4f6b-aae1-8ed3ce0cd187 61 fields · synced Jul 29, 2026