Performance Tool Organizer - Instrument Cassette - Green - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Performance Tool Organizer - Instrument Cassette - Green - 1 Count EUDAMEDPerformance Tool Organizer Green EUDAMEDFDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDPerformance Tool Organizer Green EUDAMED"Ideal for Large Specialty Instruments Customizable, removable feet Superior water flow for superb cleaning Compact styling to fit most sterilizers Attached cover that rolls back easily Dimensions: 8-3/16” x 4-1/4” x 1-7/32” Autoclavable up to 136°C/277F°" FDA UDI
- Model / Reference
- 50Z940D EUDAMEDFDA UDI
- Description
- "Ideal for Large Specialty Instruments Customizable, removable feet Superior water flow for superb cleaning Compact styling to fit most sterilizers Attached cover that rolls back easily Dimensions: 8-3/16” x 4-1/4” x 1-7/32” Autoclavable up to 136°C/277F°" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161300980 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161300980 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system 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
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 211 Millimeter FDA UDIWidth — 108 Millimeter FDA UDIHeight — 32 Millimeter FDA UDI
Category: Instrument tray, reusable
Performance Tool Organizer - Instrument Cassette - Green - 1 Count by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0840161300083F | Class I | Active |
| EUDAMED | European Union | CE/MDR | 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 503542c8-5865-415a-9e6f-f32932d9b4c8 61 fields · synced Jul 28, 2026
- EUDAMED 093c85f8-f782-4505-9be8-dfddb97d2220 61 fields · synced May 18, 2026
- FDA UDI ac647fa7-c92e-4963-bcab-a6b58629edf8 34 fields · synced May 30, 2026