Identity
- Trade Name
- Performance Tool Organizer Teal EUDAMEDFDA UDIPerformance Tool Organizer - Instrument Cassette - Teal - 1 Count EUDAMED
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Performance Tool Organizer Teal EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories 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
- 50Z940J 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
- 00840161301024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161301024 EUDAMED0840161300083F 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
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
No
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 — 211 Millimeter FDA UDIWidth — 108 Millimeter FDA UDIHeight — 32 Millimeter FDA UDI
Category: Instrument tray, reusable
Performance Tool Organizer Teal by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-00840161301024 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301024 | 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 859cbe7f-a5d4-4872-b733-1a11449c563c 61 fields · synced Jun 19, 2026
- EUDAMED 9f7a64b2-b3d3-41fe-83a1-6b94eaf756d1 61 fields · synced May 17, 2026
- FDA UDI bd3abeb1-2a98-40b5-b42a-d36a00e47fcf 34 fields · synced May 29, 2026