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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
THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE FDA UDI
Model / Reference
THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE FDA UDI
Description
THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE FDA UDI

Identifiers

Catalog Number
K2016369 FDA UDI
Primary DI / UDI-DI
00810116023448 FDA UDI
510(k) Number
K123385 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

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

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

K123385 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 d85b828a-1608-484e-b5d2-aa86d122bb4a 35 fields · synced Jun 9, 2026