Mini Mat - Replacement Instrument Strap for Mini Mat - Gray - 2 Count
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Mini Mat - Replacement Instrument Strap for Mini Mat - Gray - 2 Count EUDAMEDInstrument Strap EUDAMEDInstrument Strap (Accessory) FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDInstrument Strap EUDAMED"Replacement strap for the Mini Mat Washer-disinfect Gray Only" FDA UDI
- Model / Reference
- 50Z917I EUDAMEDFDA UDI
- Description
- "Replacement strap for the Mini Mat Washer-disinfect Gray Only" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161301291 EUDAMED10840161301298 FDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161301291 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- General-purpose bowl, 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
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 — 94 Millimeter FDA UDIWidth — 9 Millimeter FDA UDIHeight — 13 Millimeter FDA UDI
Category: Instrument tray, reusable
Mini Mat - Replacement Instrument Strap for Mini Mat - Gray - 2 Count by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840161300083F | Class I | Active |
| EUDAMED | European Union | CE/MDD | 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 1346cf90-8354-4ebd-af9d-685fa141224a 61 fields · synced Jul 10, 2026
- EUDAMED e991a7fc-3154-4dfa-b543-c9ee855b569f 61 fields · synced May 16, 2026
- FDA UDI 6c4ddb70-e4a9-4d53-9f9c-0ce19fd5614e 34 fields · synced May 30, 2026