Wedge Set Upper, 30 cm

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10004249713

by Varian Medical Systems, Inc.

Identity

Trade Name: Wedge Set Upper, 30 cm EUDAMED
Varian Collimator Accessories 30 CM wedge set upper (JITKIT) FDA UDI
Generic Name: Linear accelerator system FDA UDI
Device Name: Collimators Accessories EUDAMED
Model / Reference: 10004249713 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 00858086006474 EUDAMEDFDA UDI
Basic UDI-DI: 089947500200138PZ EUDAMED
510(k) Number: K171733 FDA UDI
K181404 FDA UDI
FDA Product Code: IYE FDA UDI
EMDN Code: Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Linear accelerator system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Wedge Set Upper, 30 cm by Varian Medical Systems, 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	089947500200138PZ	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Varian Medical Systems, Inc.
EUDAMED SRN: US-MF-000001784
Authorised Representative: Siemens Healthineers Nederland B.V. NL-AR-000000803

Sources (3)

EUDAMED 7bb7fb25-f6d2-4a0c-a878-09887655b676 61 fields · synced Jul 28, 2026
FDA UDI 0a595832-4213-4c66-9e0d-a4b98f4a4c0c 33 fields · synced May 25, 2026
EUDAMED e9249ebb-cadf-4db0-a669-8a2552d81720 61 fields · synced Jul 28, 2026