Identity
- Trade Name
- Endo Assist Teal EUDAMEDFDA UDIEndo Assist - Endo Holder - Teal - 1 Count EUDAMED
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Endo Assist Teal EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories 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
- 50Z460J 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
- 00840161302038 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302038 EUDAMED0840161300083F 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 UDIWidth — 44.5 Millimeter FDA UDIHeight — 41.3 Millimeter FDA UDI
Category: Instrument tray, reusable
Endo Assist Teal by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161302038 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302038 | 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 e3f1c502-c9b8-4764-bdf4-8fbf2d233daa 61 fields · synced Jul 24, 2026
- EUDAMED bce490fc-6d28-4ef6-b0ab-38893e12e3e6 61 fields · synced May 17, 2026
- FDA UDI ef6a3d94-09af-472d-aff0-2e8fddcd57fc 34 fields · synced May 30, 2026