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DORO® Swivel Horseshoe

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
DORO® Swivel Horseshoe FDA UDI
Generic Name
Neurosurgical headrest FDA UDI
Device Name
DORO® Swivel Horseshoe Headrest RDL Adult, w/ Extension Bar FDA UDI
Model / Reference
3036-00 FDA UDI
Description
DORO® Swivel Horseshoe Headrest RDL Adult, w/ Extension Bar FDA UDI

Identifiers

Primary DI / UDI-DI
04250435502334 FDA UDI
510(k) Number
K032331 FDA UDI
K063494 FDA UDI
FDA Product Code
HBL FDA UDI
GMDN Term
Neurosurgical headrest 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

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

No

FDA UDI

Category: Neurosurgical headrest

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

Similar devices

Also classified as Neurosurgical headrest.

Cleared under the same submission

K032331 also covers:

K063494 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 6abfec1b-cf56-4ee4-bbff-ee992e04890f 34 fields · synced May 30, 2026