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Septoject Xl Infiltration
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 335SS/0.4 x 21
Identity
- Trade Name
- Septoject XL EUDAMEDSEPTOJECT XL INFILTRATION FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Septoject XL EUDAMED100 single use needles FDA UDI
- Model / Reference
- 335SS/0.4 x 21 EUDAMED01N1500 FDA UDI
- Description
- 100 single use needles FDA UDI
Identifiers
- Catalog Number
- 01N1500 FDA UDI
- Primary DI / UDI-DI
- D-FR-MF-00001699200022PD EUDAMED03701398101313 FDA UDI
- Basic UDI-DI
- B-FR-MF-00001699200022PD EUDAMED
- FDA Product Code
- DZM FDA UDI
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental syringe needle, single-use
Septoject Xl Infiltration by Septodont Sas Specialites Septodont — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental syringe needle, single-use.
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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
- Septodont Sas Specialites Septodont
Sources (2)
- FDA UDI 7021836e-bd43-4b0e-94cf-c10838ef1393 34 fields · synced Aug 4, 2026
- EUDAMED 311290b3-4919-444f-881a-452d200e3dfe 61 fields · synced Aug 4, 2026