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Sleeve for extraoral X-Ray devices

FDA UDI

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name
Sleeve for extraoral X-Ray devices FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
Hygienic protective head holder GALILEOS FDA UDI
Model / Reference
6234400 FDA UDI
Description
Hygienic protective head holder GALILEOS FDA UDI

Identifiers

Primary DI / UDI-DI
E27662344002 FDA UDI
FDA Product Code
OAS FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary panoramic/tomographic dental x-ray system, digital

Sleeve for extraoral X-Ray devices by Sirona Dental Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary panoramic/tomographic dental x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sirona Dental Systems GmbH

Sources (1)

  • FDA UDI 94bd80f7-2a05-4549-bc38-e2f474355d36 34 fields · synced Jun 8, 2026