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Lithotriptor Handle

EUDAMEDFDA UDI

Class I (EU MDR)

Ref SLH-1

by Wilson-Cook Medical, Inc.

Identity

Trade Name
Lithotriptor Handle EUDAMED
Soehendra FDA UDI
Generic Name
Stone/foreign-body extraction set FDA UDI
Device Name
Soehendra Lithotriptor Handle EUDAMEDFDA UDI
Model / Reference
SLH-1 EUDAMED
G21860 FDA UDI
Description
Soehendra Lithotriptor Handle FDA UDI

Identifiers

Catalog Number
SLH-1 FDA UDI
Primary DI / UDI-DI
00827002218604 EUDAMEDFDA UDI
Basic UDI-DI
0827002WCM00000000004MG EUDAMED
FDA Product Code
LQC FDA UDI
EMDN Code
G030502 LITHOTRIPSY DEVICES EUDAMED
GMDN Term
Stone/foreign-body extraction set FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.4500 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Lithotriptor Handle by Wilson-Cook Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.
EUDAMED SRN
US-MF-000002658
Authorised Representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Sources (2)

  • EUDAMED 80b1d0ba-2227-40e4-b2da-c1d17aa35865 61 fields · synced Oct 8, 2026
  • FDA UDI 0c3d2907-f5a2-4627-9299-53cf5ee4e1ee 36 fields · synced May 30, 2026