Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Microtip applicators EUDAMEDdental micro applicator FDA UDI
- Model / Reference
- TF-448 (HS) EUDAMED5702051 EUDAMEDFDA UDI
- Description
- dental micro applicator FDA UDI
Identifiers
- Catalog Number
- 5702051 FDA UDI
- Primary DI / UDI-DI
- 10304040132248 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040444801DH EUDAMED
- Unit of Use DI
- 00304040132241 EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
Yes
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
Category: Dental material injection cannula, single-use
Henry Schein by Henry Schein, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 03040444801DH | 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 83d4cc8c-1c57-42fa-bbaa-be6e8846b4a7 61 fields · synced Jun 1, 2026
- FDA UDI d951d63d-1800-4edd-96f1-6be169f98f42 34 fields · synced May 30, 2026