Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Radiation shielding goggles/spectacles FDA UDI
- Device Name
- Universal curing light shields EUDAMEDUniversal Curing Light Shield FDA UDI
- Model / Reference
- TF-368 (HS) EUDAMED9007979 EUDAMEDFDA UDI
- Description
- Universal Curing Light Shield FDA UDI
Identifiers
- Catalog Number
- 9007979 FDA UDI
- Primary DI / UDI-DI
- 10304040051822 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040436801DL EUDAMED
- Unit of Use DI
- 00304040051825 EUDAMED
- FDA Product Code
- HOY FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Radiation shielding goggles/spectacles FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4750 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
No
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
No
FDA UDI
Henry Schein by Henry Schein, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03040436801DL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (2)
- EUDAMED 18d2862d-5c82-447e-bc52-8cb9d228d4fd 61 fields · synced May 31, 2026
- FDA UDI 00b4e34f-349c-41c6-9dad-bb6d2b7f4dea 34 fields · synced May 26, 2026