Identity
- Trade Name
- Steri-Endo Guard Hand Copper EUDAMEDSteri-Endo Guard - Endo Holder - Hand - Copper - 1 Count EUDAMEDSteri-Endo Guard Hand FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Steri-Endo Guard Hand Copper EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDOrganizes 16 hand files/reamers. FDA UDI
- Model / Reference
- 50Z450U EUDAMEDU-Copper FDA UDI
- Description
- Organizes 16 hand files/reamers. FDA UDI
Identifiers
- Catalog Number
- 50Z450U FDA UDI
- Primary DI / UDI-DI
- 00840161301550 EUDAMEDD68550Z450U0 FDA UDI
- Basic UDI-DI
- B-00840161301550 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Sterilization packaging, 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
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
Category: Instrument tray, reusable
Steri-Endo Guard Hand Copper by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | B-00840161301550 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-00840161301550 | 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 f9059d18-d078-4e1c-8c52-0985052c7e4c 61 fields · synced Aug 3, 2026
- EUDAMED 3f7d0792-1177-4050-8620-106827680db8 61 fields · synced May 17, 2026
- FDA UDI 95cf7326-5045-4f99-b85b-5a42e575947d 34 fields · synced May 29, 2026