Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech America, Inc.

Identity

Trade Name: Dornier MedTech FDA UDI
Generic Name: Ureteral introduction sheath FDA UDI
Device Name: Dornier Magellan Ureteral Access Sheath, 12/14Fr x 35cm FDA UDI
Model / Reference: Dornier Magellan Ureteral Access Sheath, 12/14Fr x 35cm FDA UDI
Description: Dornier Magellan Ureteral Access Sheath, 12/14Fr x 35cm FDA UDI

Identifiers

Catalog Number: MAG12435 FDA UDI
Primary DI / UDI-DI: 00810116021628 FDA UDI
510(k) Number: K201815 FDA UDI
FDA Product Code: FED FDA UDI
GMDN Term: Ureteral introduction sheath FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ureteral introduction sheath

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

Similar devices

Also classified as Ureteral introduction sheath.

Manawa Access Sheath — ENVASTE LTD · Class IIa
Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II

Cleared under the same submission

K201815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dornier MedTech America, Inc.

Sources (1)

FDA UDI e89210db-0c7c-44f9-b32c-7ced611002a4 35 fields · synced Jun 9, 2026