Endo Assist Stand - Replacement Foam for Endo Assist Stand - 144 Count

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 50Z466V

by Zirc Dental Products Inc.

Identity

Trade Name: Endo Assist Stand - Replacement Foam for Endo Assist Stand - 144 Count EUDAMED
Assist Stand Foam 144pk EUDAMED
Foam Insert (Single Use) 144 pack FDA UDI
Generic Name: Dental suction system in-line filter FDA UDI
Device Name: Dental Cleaning, Sterilization, Disinfection Accessories EUDAMED
Assist Stand Foam 144pk EUDAMED
"Foam refills for Assist Stand Single use only/disposable" FDA UDI
Model / Reference: 50Z466V EUDAMEDFDA UDI
Description: "Foam refills for Assist Stand Single use only/disposable" FDA UDI

Identifiers

Primary DI / UDI-DI: 00840161302175 EUDAMED
10840161302172 FDA UDI
Basic UDI-DI: 0840161300083F EUDAMED
B-00840161302175 EUDAMED
FDA Product Code: DYN FDA UDI
EMDN Code: S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Dental suction system in-line filter FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.6640 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 45 Millimeter FDA UDI
Width — 23 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Instrument tray, reusable

Endo Assist Stand - Replacement Foam for Endo Assist Stand - 144 Count by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA…

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	0840161300083F	Class I	Active
EUDAMED	European Union	CE/MDR	0840161300083F	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Zirc Dental Products Inc.
EUDAMED SRN: US-MF-000021065
Authorised Representative: Medicom GmbH DE-AR-000005612

Sources (3)

EUDAMED 7b5d454e-7a3f-4bf9-a09a-55e943d15476 61 fields · synced Jul 30, 2026
EUDAMED 883ea9c5-7366-4fd0-a52a-7d22b7beec28 61 fields · synced May 17, 2026
FDA UDI c592afd8-da68-45e6-967c-613a30c8cc14 34 fields · synced May 30, 2026