Identity
- Trade Name
- SE Cushion FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- SE Cushion 20pk FDA UDI
- Model / Reference
- 50Z970-360 FDA UDI
- Description
- SE Cushion 20pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840161304770 FDA UDI
- FDA Product Code
- DYN FDA UDI
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Surgical instrument guard, single-use
SE Cushion by Zirc Dental Products, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products, Inc.
Sources (2)
- FDA UDI 62e55ad6-a4f2-455a-a783-1b576435b6da 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026