← Back to catalogue

Fraxion Thermoplastic Mask Head (10 PCS)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P10106-300

by 3C-Medical Intelligence GmbH

Identity

Trade Name
Fraxion Thermoplastic Mask Head (10 PCS) EUDAMED
Fraxion™ FDA UDI
Generic Name
Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Device Name
Fraxion EUDAMED
The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. FDA UDI
Model / Reference
P10106-300 EUDAMEDFDA UDI
Description
The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. FDA UDI

Identifiers

Primary DI / UDI-DI
04056719002060 EUDAMEDFDA UDI
Basic UDI-DI
04056719BUDI0000000002HW EUDAMED
Unit of Use DI
04056719002169 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Fraxion Thermoplastic Mask Head (10 PCS) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (3)

  • EUDAMED 8f8a5e33-3f9b-4b8f-a9e5-94d8b203f98d 61 fields · synced Jun 19, 2026
  • FDA UDI 114c27a3-9430-4caf-a5a9-b6914d69f409 35 fields · synced May 30, 2026
  • EUDAMED 4a854b83-c02e-4499-8723-e9dedf5cfd9a 61 fields · synced Jun 19, 2026