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DORO® Headrest System Radiolucent

FDA UDI

Class II (US FDA UDI)

by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Identity

Trade Name
DORO® Headrest System Radiolucent FDA UDI
Generic Name
Skull clamp FDA UDI
Device Name
DORO® Headrest System Radiolucent complete consisting of 3006-20 3030-002 3034-00 3033-00 3032-20 3023-10 3031-00 FDA UDI
Model / Reference
3030-00 FDA UDI
Description
DORO® Headrest System Radiolucent complete consisting of 3006-20 3030-002 3034-00 3033-00 3032-20 3023-10 3031-00 FDA UDI

Identifiers

Primary DI / UDI-DI
04250435501887 FDA UDI
510(k) Number
K032331 FDA UDI
FDA Product Code
HBL FDA UDI
GMDN Term
Skull clamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4460 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

DORO® Headrest System Radiolucent by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung — Class II — FDA UDI — listed in…

Cleared under the same submission

K032331 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Sources (1)

  • FDA UDI 44301f9e-14c5-473b-9f67-77e223cd22d8 35 fields · synced May 30, 2026