Identity
- Trade Name
- Irriflex FDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- Irriflex is a flexible cannula with radial opening for liquid ejection along the canal walls. Box of 100 cannulas. FDA UDI
- Model / Reference
- 21402 FDA UDI
- Description
- Irriflex is a flexible cannula with radial opening for liquid ejection along the canal walls. Box of 100 cannulas. FDA UDI
Identifiers
- Catalog Number
- 21402 FDA UDI
- Primary DI / UDI-DI
- 07640159160137 FDA UDI
- FDA Product Code
- EIC FDA UDI
- GMDN Term
- Dental irrigation/aspiration syringe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Irriflex by Produits dentaires S.A. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Produits dentaires S.A.
Sources (1)
- FDA UDI fe0d18cf-8c4b-4a45-8e05-b47e487ed0d1 37 fields · synced May 30, 2026