Identity
- Trade Name
- Steri-Endo Guard Engine Beige EUDAMEDSteri-Endo Guard - Endo Holder - Engine - Beige - 1 Count EUDAMEDSteri-Endo Guard Biege FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Steri-Endo Guard Engine Beige EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMED"Holds most lengths for staging, cleaning, sterilizing files and reamers Millimeter gauge measures files and positions rubber stopper Right or left hand use Single foam insert cleans and holds files Sterilization counter on locking bar tracks the number of times instruments have been sterilized Organizes up to 11 Engine and 5 Hand files Dimensions: 5-3/8"" x 3/8"" x 2-3/16"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
- Model / Reference
- 50Z452G EUDAMEDFDA UDI
- Description
- "Holds most lengths for staging, cleaning, sterilizing files and reamers Millimeter gauge measures files and positions rubber stopper Right or left hand use Single foam insert cleans and holds files Sterilization counter on locking bar tracks the number of times instruments have been sterilized Organizes up to 11 Engine and 5 Hand files Dimensions: 5-3/8"" x 3/8"" x 2-3/16"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161301338 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161301338 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument transport trolley system 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 — 136.5 Millimeter FDA UDIWidth — 9.5 Millimeter FDA UDIHeight — 55.6 Millimeter FDA UDI
Category: Instrument tray, reusable
Steri-Endo Guard Engine Beige by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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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-00840161301338 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301338 | 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 9ac2dd96-0884-4fc7-ba95-5cee2f62681b 61 fields · synced Jul 17, 2026
- EUDAMED 46c287a0-bc25-4f29-b9c4-ed97febf98d1 61 fields · synced May 18, 2026
- FDA UDI c24445e1-4a24-408c-9e8e-57e156bd58f0 34 fields · synced May 30, 2026