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Endo Assist - Endo Holder - Gray - 1 Count

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 50Z460I

by Zirc Dental Products Inc.

Identity

Trade Name
Endo Assist - Endo Holder - Gray - 1 Count EUDAMED
Endo Assist Gray EUDAMEDFDA UDI
Generic Name
Surgical instrument guard, reusable FDA UDI
Device Name
Dental Cleaning, Sterilization, Disinfection Accessories EUDAMED
Endo Assist Gray EUDAMED
"Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Model / Reference
50Z460I EUDAMEDFDA UDI
Description
"Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI

Identifiers

Primary DI / UDI-DI
00840161302014 EUDAMEDFDA UDI
Basic UDI-DI
0840161300083F EUDAMED
B-00840161302014 EUDAMED
FDA Product Code
FSM FDA UDI
EMDN Code
S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
GMDN Term
Surgical instrument guard, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 38.1 Millimeter FDA UDI
Width — 44.5 Millimeter FDA UDI
Height — 41.3 Millimeter FDA UDI

Category: Instrument tray, reusable

Endo Assist - Endo Holder - Gray - 1 Count by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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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 a375d3f7-16d7-4ad6-9f80-b59d368115b7 61 fields · synced Sep 17, 2026
  • EUDAMED 7cff8812-210d-48e2-be35-b7088a37e258 61 fields · synced May 18, 2026
  • FDA UDI f7f3dffb-fe55-4037-860f-729504675515 34 fields · synced May 30, 2026