Identity
- Trade Name
- Steri-Endo Guard Engine Neon Green EUDAMEDSteri-Endo Guard - Endo Holder - Engine - Neon Green - 1 Count EUDAMEDSteri-Endo Guard Neon Green FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Steri-Endo Guard Engine Neon Green 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
- 50Z452P 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
- 00840161301420 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840161301420 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
Steri-Endo Guard Engine Neon Green 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-00840161301420 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301420 | 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 dc96b130-24c4-4fb3-9a07-0ddb336edc8a 61 fields · synced Jul 25, 2026
- EUDAMED 34b4f2f1-da6d-4602-a6ec-88bf458c795f 61 fields · synced May 19, 2026
- FDA UDI c0403955-3617-4dce-9475-846a29261274 34 fields · synced May 30, 2026