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DORO® Headrest System

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
DORO® Headrest System FDA UDI
Generic Name
Skull clamp FDA UDI
Device Name
DORO® Intra-OP CT Headrest System consisting of 3006-20 3030-001 3034-00 3033-10 3032-21 3032-20 3032-10 3031-00 FDA UDI
Model / Reference
3030-300 FDA UDI
Description
DORO® Intra-OP CT Headrest System consisting of 3006-20 3030-001 3034-00 3033-10 3032-21 3032-20 3032-10 3031-00 FDA UDI

Identifiers

Primary DI / UDI-DI
04250435509913 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
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

Category: Skull clamp

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

Similar devices

Also classified as Skull clamp.

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 2b38da16-5894-4240-8244-f46098b6e175 34 fields · synced May 30, 2026