Identity
- Trade Name
- Ultra Safety Plus Twist kit 25G Long FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- 100 needles 25G long (Red) and 1 handle (to be sterilized) FDA UDI
- Model / Reference
- 01N4552 FDA UDI
- Description
- 100 needles 25G long (Red) and 1 handle (to be sterilized) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701398105328 FDA UDI
- FDA Product Code
- EJI FDA UDIDZM FDA UDI
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 FDA UDI872.4730 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ultra Safety Plus Twist kit 25G Long by Septodont Sas Specialites Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Sas Specialites Septodont
Sources (1)
- FDA UDI c834ad51-1ee7-464b-b10f-a41321c010be 35 fields · synced May 31, 2026