Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- Air-Water Syringe Tips EUDAMEDSure Tip FDA UDI
- Model / Reference
- 1028981 EUDAMEDFDA UDITF-225 EUDAMED
- Description
- Sure Tip FDA UDI
Identifiers
- Catalog Number
- 1028981 FDA UDI
- Primary DI / UDI-DI
- 10304040051433 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10304040051433 EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- A070102 IRRIGATION TUBING ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
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
Category: Dental delivery system irrigation handpiece
Henry Schein by Henry Schein, 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
- Henry Schein, Inc.
Sources (2)
- FDA UDI 3ab5a06c-d539-48d1-818a-a9ff9eb861ec 34 fields · synced Oct 5, 2026
- EUDAMED ad266e57-c699-4a66-b7cf-04bd725ba2a6 61 fields · synced Oct 5, 2026