Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Digital imaging cassette/phosphor plate FDA UDI
- Device Name
- Phosphor plate barrier envelopes EUDAMEDMaxi-Gard Barrier Envelope HL Size 0 FDA UDI
- Model / Reference
- TF-433 (HS) EUDAMED5701561 EUDAMEDFDA UDI
- Description
- Maxi-Gard Barrier Envelope HL Size 0 FDA UDI
Identifiers
- Catalog Number
- 5701561 FDA UDI
- Primary DI / UDI-DI
- 10304040118310 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040443301CH EUDAMED
- Unit of Use DI
- 00304040118313 EUDAMED
- FDA Product Code
- EGZ FDA UDI
- EMDN Code
- Z11079085 VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Digital imaging cassette/phosphor plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1905 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
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
Yes
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 | 03040443301CH | 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 fdac7232-4f2e-422b-9359-4582a68cb331 61 fields · synced Jul 22, 2026
- FDA UDI 03f3741e-bcf9-46ac-89ab-7da7ff56ecb1 34 fields · synced May 30, 2026