Identity
- Trade Name
- Mighty Mixer Bowl 36pk Assorted EUDAMEDMighty Mixer Bowl FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Non-Sterile Dental Mixing Accessories EUDAMED"Mighty Mixer Bowl 36pk Assorted, Disposable, eliminating cleanup time, Fits securely into mixing bowl without slippage, Free-standing for use with or without mixing bowl, Capable for use with electric Alginate mixers 9 x Teal 9 x Neon Blue 9 x Neon Green 9 x Neon Purple" FDA UDI
- Model / Reference
- 50Z505-ASTD EUDAMEDFDA UDI
- Description
- "Mighty Mixer Bowl 36pk Assorted, Disposable, eliminating cleanup time, Fits securely into mixing bowl without slippage, Free-standing for use with or without mixing bowl, Capable for use with electric Alginate mixers 9 x Teal 9 x Neon Blue 9 x Neon Green 9 x Neon Purple" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304094 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300063B EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- General-purpose bowl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 267 Millimeter FDA UDIWidth — 254 Millimeter FDA UDIHeight — 114 Millimeter FDA UDI
Category: Device sterilization/disinfection container, reusable
Mighty Mixer Bowl 36pk Assorted by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840161300063B | 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 (2)
- EUDAMED 66d46802-d47e-4f34-8ecf-cd2635b6f5a7 61 fields · synced Jul 31, 2026
- FDA UDI d84fb4e7-1fec-44ec-8d30-ff4a95581fca 34 fields · synced May 30, 2026