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Steri-Endo Guard - Endo Holder - Engine - Red - 1 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50Z452M
Identity
- Trade Name
- Steri-Endo Guard - Endo Holder - Engine - Red - 1 Count EUDAMEDSteri-Endo Guard Engine Red EUDAMEDSteri-Endo Guard Red FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDSteri-Endo Guard Engine Red 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
- 50Z452M 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
- 00840161301376 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161301376 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 - Endo Holder - Engine - Red - 1 Count by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Instrument tray, reusable.
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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 | 0840161300083F | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0840161300083F | 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 232edc4b-470f-422c-b328-7e947b06106f 61 fields · synced Jun 18, 2026
- EUDAMED 836bca9b-7612-4fb4-9b2d-4056489cd3c1 61 fields · synced May 18, 2026
- FDA UDI 87d0e660-284c-48f7-b170-40af4b986b7a 34 fields · synced May 30, 2026