Identity
- Trade Name
- SEPTODONT FUSION(TITANIUM) SYRINGE FDA UDI
- Generic Name
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
- Device Name
- Aspirating Syringe Medium Titanium Fusion Septodont USA FDA UDI
- Model / Reference
- 01N2105 FDA UDI
- Description
- Aspirating Syringe Medium Titanium Fusion Septodont USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00303620000055 FDA UDI
- FDA Product Code
- EJI FDA UDI
- GMDN Term
- Syringe-loaded medication/vaccine injector, manual, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Syringe-loaded medication/vaccine injector, manual, professional
Septodont Fusion(titanium) Syringe by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Septodont
Sources (1)
- FDA UDI 63102879-6247-465c-87f9-b19197951453 33 fields · synced May 30, 2026