Identity
- Trade Name
- Steri-Endo Guard Hand Blue EUDAMEDSteri-Endo Guard - Endo Holder - Hand - Blue - 1 Count EUDAMEDSteri-Endo Guard Hand FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Steri-Endo Guard Hand Blue EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDOrganizes 16 hand files/reamers. FDA UDI
- Model / Reference
- 50Z450B EUDAMEDB-Blue FDA UDI
- Description
- Organizes 16 hand files/reamers. FDA UDI
Identifiers
- Catalog Number
- 50Z450B FDA UDI
- Primary DI / UDI-DI
- 00840161301475 EUDAMEDD68550Z450B0 FDA UDI
- Basic UDI-DI
- B-00840161301475 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 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-00840161301475 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301475 | 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 38f7be67-72b8-4fbe-9713-df8639ad7eec 61 fields · synced Jul 12, 2026
- EUDAMED 108e684d-4510-4e86-a2fd-1ea4b1e35d8f 61 fields · synced May 18, 2026
- FDA UDI 93af5d19-c7cd-4efe-920e-ba26341defc6 34 fields · synced May 30, 2026