Identity
- Trade Name
- SE Cushion® EUDAMEDSE Cushion FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- SE Cushion EUDAMEDSE Cushion 100pk FDA UDI
- Model / Reference
- 50Z970 EUDAMEDFDA UDI
- Description
- SE Cushion 100pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840161304766 EUDAMED10840161304763 FDA UDI
- Basic UDI-DI
- B-00840161304766 EUDAMED
- FDA Product Code
- DYN FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
- Outer Diameter — 15.5 Millimeter FDA UDIHeight — 25.4 Millimeter FDA UDI
SE Cushion® by Zirc Dental Products, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840161304766 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (2)
- EUDAMED 9be477d3-812f-4f44-83c0-d226d8ffb823 61 fields · synced May 31, 2026
- FDA UDI e0cdc744-037c-4d29-a3f4-085d34064355 34 fields · synced May 30, 2026