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Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech America, Inc.

Identity

Trade Name
Dornier MedTech FDA UDI
Generic Name
Laser lithotripsy system FDA UDI
Device Name
200 Micron SU Thulio Performance Ball-Tip 3m Fiber FDA UDI
Model / Reference
200 Micron SU Thulio Performance Ball-Tip 3m Fiber FDA UDI
Description
200 Micron SU Thulio Performance Ball-Tip 3m Fiber FDA UDI

Identifiers

Catalog Number
K2016367 FDA UDI
Primary DI / UDI-DI
00810116023332 FDA UDI
510(k) Number
K161771 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Laser lithotripsy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laser lithotripsy system

Dornier MedTech by Dornier MedTech America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser lithotripsy system.

Cleared under the same submission

K161771 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA UDI 6cbf5f18-9154-4544-896a-b8d49a9c242e 35 fields · synced Jun 9, 2026