Identity
- Trade Name
- EM45 SurgiFlexo Tip FDA UDI
- Generic Name
- Dental suction system cannula, single-use FDA UDI
- Device Name
- Flexible sterile aspirator tip suitable for surgical aspiration, especially for apicoectomies, gingival grafts and planetology operations with limited operating space. Ideal in hard-to-reach areas, such as in wisdom tooth operations. The possibility to flex the tube and unscrew the tip allows its adaptation to different aspiration needs during the various stages of the operation. Each aspirator tip is packed in a sterile medical blister with a double adhesive label to provide maximum traceability. Each pack includes 20 aspirator tips and 2 adapters: one adapter from 6,5 mm to 11 mm, the other from 11 mm to 16 mm, providing universal compatibility. Classification: Medical Device Class Ila Dimensions: 18 cm | 15,5 cm – without tip Box: 20pcs FDA UDI
- Model / Reference
- EM45 FDA UDI
- Description
- Flexible sterile aspirator tip suitable for surgical aspiration, especially for apicoectomies, gingival grafts and planetology operations with limited operating space. Ideal in hard-to-reach areas, such as in wisdom tooth operations. The possibility to flex the tube and unscrew the tip allows its adaptation to different aspiration needs during the various stages of the operation. Each aspirator tip is packed in a sterile medical blister with a double adhesive label to provide maximum traceability. Each pack includes 20 aspirator tips and 2 adapters: one adapter from 6,5 mm to 11 mm, the other from 11 mm to 16 mm, providing universal compatibility. Classification: Medical Device Class Ila Dimensions: 18 cm | 15,5 cm – without tip Box: 20pcs FDA UDI
Identifiers
- Catalog Number
- 22810003 FDA UDI
- Primary DI / UDI-DI
- E30722810003 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Dental suction system cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental suction system cannula, single-use
EM45 SurgiFlexo Tip by Euronda Spa — 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
- Euronda Spa
Sources (1)
- FDA UDI c9241e4e-3269-4ef8-a9ed-78752dad72fb 34 fields · synced May 30, 2026