Identity
- Trade Name
- Foam Inserts 144pk EUDAMEDSteri-Endo Guard, Endo Assist - Replacement Foam for Steri-Endo Guard and Endo Assist - 144 Count EUDAMEDFoam Insert (Single Use) 144-pack FDA UDI
- Generic Name
- Dental suction system in-line filter FDA UDI
- Device Name
- Foam Inserts 144pk EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDFoam refills for Endo Guards and Endo Assist FDA UDI
- Model / Reference
- 50Z451V EUDAMEDFDA UDI
- Description
- Foam refills for Endo Guards and Endo Assist FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302151 EUDAMED10840161302158 FDA UDI
- Basic UDI-DI
- B-00840161302151 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- DYN FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDS010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Dental suction system in-line filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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 — 45 Millimeter FDA UDIWidth — 23 Millimeter FDA UDIHeight — 15 Millimeter FDA UDI
Foam Inserts 144pk 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-00840161302151 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161302151 | 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 eb4e7a3c-cb33-410b-81a9-4b644d3c53e7 61 fields · synced Jul 11, 2026
- EUDAMED 6e4b7b8a-f388-4861-a7a6-99cc00a6fd90 61 fields · synced May 16, 2026
- FDA UDI eecbb908-b7b1-4c7d-9fed-dcf57cfd022e 34 fields · synced May 26, 2026