Identity
- Trade Name
- Steri-Endo Guard Hand Midnight Blue EUDAMEDSteri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count EUDAMEDSteri-Endo Guard Hand FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Steri-Endo Guard Hand Midnight Blue EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDOrganizes 16 hand files/reamers. FDA UDI
- Model / Reference
- 50Z450T EUDAMEDT-Midnight Blue FDA UDI
- Description
- Organizes 16 hand files/reamers. FDA UDI
Identifiers
- Catalog Number
- 50Z450T FDA UDI
- Primary DI / UDI-DI
- 00840161301543 EUDAMEDD68550Z450T0 FDA UDI
- Basic UDI-DI
- B-00840161301543 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
Steri-Endo Guard Hand Midnight Blue by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00840161301543 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301543 | 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 9c312afd-5c07-43d3-94a2-3afb0312da19 61 fields · synced Jul 11, 2026
- EUDAMED 5589560d-85c9-4c86-add2-24d9a823c467 61 fields · synced May 17, 2026
- FDA UDI 065da208-8042-4f40-a8e3-e79dbc0fc8b7 34 fields · synced May 30, 2026