Identity
- Trade Name
- Delrin Spatula 10pk EUDAMEDDelrin Spatula FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- Non-Sterile Dental Mixing Accessories EUDAMEDDelrin Spatula - 10 Count FDA UDI
- Model / Reference
- 50Z523 EUDAMEDFDA UDI
- Description
- Delrin Spatula - 10 Count FDA UDI
Identifiers
- Catalog Number
- 50Z523 FDA UDI
- Primary DI / UDI-DI
- 00840161304148 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300063B EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159013,V9099 EUDAMED
- GMDN Term
- Dental spatula, 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
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 — 162 Millimeter FDA UDIWidth — 6 Millimeter FDA UDIHeight — 10 Millimeter FDA UDI
Delrin Spatula 10pk by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 51a7a4a6-5494-4139-b2de-9850acc9e14a 61 fields · synced Jul 10, 2026
- FDA UDI 01ff0ec7-9e32-46f2-8b10-5e1036bae595 35 fields · synced May 30, 2026