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Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech GmbH

Identity

Trade Name
Dornier MedTech FDA UDI
Generic Name
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI
Device Name
Genesis Urology Imaging System, Left, UV, FPD, 80 KW, 480 V FDA UDI
Model / Reference
Genesis FDA UDI
Description
Genesis Urology Imaging System, Left, UV, FPD, 80 KW, 480 V FDA UDI

Identifiers

Catalog Number
K1041701 FDA UDI
Primary DI / UDI-DI
04049957005566 FDA UDI
510(k) Number
K122768 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

Yes

FDA UDI

Category: Stationary uro-gynaecological fluoroscopic x-ray system, digital

Dornier MedTech by Dornier MedTech GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary uro-gynaecological fluoroscopic x-ray system, digital.

Cleared under the same submission

K122768 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dornier MedTech GmbH

Sources (1)

  • FDA UDI dba30b92-db25-4732-92ea-78e585fdd228 35 fields · synced May 31, 2026