Identity
- Trade Name
- Assist Stand EUDAMEDFDA UDIEndo Assist Stand - Endo Holder - 1 Count EUDAMED
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Assist Stand EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED"Dense foam cleans bio-debris easier and faster and holds Endo instruments in an upright position Square shape fits great in procedure tub Thicker foam prevents solution from leaking - has rounded corners for easy cleaning Available in black only Dimensions: 1-7/8"" x 1-7/8"" x 1-1/4"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
- Model / Reference
- 50Z462 EUDAMEDFDA UDI
- Description
- "Dense foam cleans bio-debris easier and faster and holds Endo instruments in an upright position Square shape fits great in procedure tub Thicker foam prevents solution from leaking - has rounded corners for easy cleaning Available in black only Dimensions: 1-7/8"" x 1-7/8"" x 1-1/4"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302137 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161302137 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 — 46.6 Millimeter FDA UDIWidth — 46.6 Millimeter FDA UDIHeight — 31.8 Millimeter FDA UDI
Assist Stand by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00840161302137 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302137 | 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 41a9b694-db3a-41e7-938e-8995b0323f50 61 fields · synced Jul 15, 2026
- EUDAMED ac2cbbc4-eb87-425f-aa24-7c2d337cf559 61 fields · synced May 19, 2026
- FDA UDI 4e880741-311d-44a0-b17b-4743c82e0c43 34 fields · synced May 30, 2026