Identity
- Trade Name
- Foam Inserts 48pk EUDAMEDSteri-Endo Guard, Endo Assist - Replacement Foam for Steri-Endo Guard and Endo Assist - 48 Count EUDAMEDFoam Insert (Accessory) (Single-Use) 48-pack FDA UDI
- Generic Name
- Dental suction system in-line filter FDA UDI
- Device Name
- Foam Inserts 48pk EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDFoam refills for Endo Guards and Endo Assist FDA UDI
- Model / Reference
- 50Z451 EUDAMEDFDA UDI
- Description
- Foam refills for Endo Guards and Endo Assist FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161302144 EUDAMED10840161302141 FDA UDI
- Basic UDI-DI
- B-00840161302144 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 48pk by Zirc Dental Products, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | B-00840161302144 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-00840161302144 | 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 8893d8df-6e65-4510-952f-cf7c96ea989d 61 fields · synced Jul 23, 2026
- EUDAMED 3112cddb-5941-4af7-a665-2bd9402bd547 61 fields · synced May 17, 2026
- FDA UDI 87fe0e54-3ab3-48d0-bf75-fc4f60e19cd1 34 fields · synced May 30, 2026