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Performance Tool Organizer - Replacement Feet for Performance Tool Organizer - …
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z944
Identity
- Trade Name
- Performance Tool Organizer - Replacement Feet for Performance Tool Organizer - 2 Count EUDAMEDPerformance Tool Organizer Replacement Feet EUDAMEDPerformance Tool Organaizer Replacement Feet (Accessory) FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDPerformance Tool Organizer Feet EUDAMED"Two Strips of 10 Gray Only" FDA UDI
- Model / Reference
- 50Z944 EUDAMEDFDA UDI
- Description
- "Two Strips of 10 Gray Only" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161301123 EUDAMED10840161301120 FDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161301123 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
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 — 111 Millimeter FDA UDIWidth — 25 Millimeter FDA UDIHeight — 10 Millimeter FDA UDI
Category: Instrument tray, reusable
Performance Tool Organizer - Replacement Feet for Performance Tool Organizer - … by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in…
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Also classified as Instrument tray, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
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 f8a1a4f6-0ae5-4d23-94bb-2513bd392cef 61 fields · synced Jun 20, 2026
- EUDAMED b8fc7fdd-6545-4bbc-a372-f0c676b65308 61 fields · synced May 17, 2026
- FDA UDI 03df4ce4-8d84-49bd-b696-b449030f4ae6 34 fields · synced May 30, 2026