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Fraxion Vacuum Cushion Plus M (1.4 L)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10106-213

by 3C-Medical Intelligence GmbH

Identity

Trade Name
Fraxion Vacuum Cushion Plus M (1.4 L) EUDAMED
Fraxion FDA UDI
Generic Name
Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Device Name
Fraxion EUDAMED
The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. FDA UDI
Model / Reference
P10106-213 EUDAMEDFDA UDI
Description
The FRAXION™ Vacuum cushions are formed to the patients head and enable highly accurate patient repositioning. Each cushion will be moulded individually for each patient and will be stored together with all patient-specific parts in the storage box for the whole treatment time. FDA UDI

Identifiers

Catalog Number
P10106-213 FDA UDI
Primary DI / UDI-DI
04056719001551 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000002HW EUDAMED
Direct Marketing DI
04056719001551 EUDAMED
510(k) Number
K112210 FDA UDI
FDA Product Code
IYE FDA UDI
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
GMDN Term
Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Market of Registration
Germany 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Fraxion Vacuum Cushion Plus M (1.4 L) by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3C-Medical Intelligence GmbH
EUDAMED SRN
DE-MF-000023763

Sources (3)

  • EUDAMED 4fa0c8de-861b-4d73-8e72-6faedd3766f5 61 fields · synced Jul 19, 2026
  • FDA UDI ce446596-b56c-4aab-b5fb-f53127099ec1 35 fields · synced May 30, 2026
  • EUDAMED c052b0a1-467a-48e3-ae21-0ccf3ca0ab27 61 fields · synced Jul 19, 2026